**Review**

**Division of Surveillance, Research, and Communication Support**

**NDA \#** 21-229

**Drug:** Omeprazole Magnesium Tablets

**Sponsor:** The Procter & Gamble Co.

**Identification:** Study 02255 Label Comprehension

**Date of Reviewed Document:** July 20, 2001

**Reviewer:** Karen Lechter, J.D., Ph.D.**,** HFD-410

**Review Completed:** May 6, 2002

# Overview

The results of this label comprehension study strongly suggest that the
tested label does not adequately convey to consumers the product is not
for episodic use and that it is only for prevention. Further, it is
likely that many who take contraindicated medications and many with
contraindicated conditions will believe they can take Prilosec 1 without
checking with a health professional. Some of the high levels of correct
responses may have been due to an artifact of the questioning by which
almost all questions required responses that the product should not be
used or a health professional should be consulted.

# Communication Objectives

The following are the key communication objectives of the study:

1)  Consumers understand the uses of the product

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a)  Prilosec 1 is for prevention of frequent heartburn.

b)  Prilosec 1 is only for those who suffer heartburn two or more days a
    week.

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```
2)  Consumers understand who can and cannot use Prilosec 1 (warnings).

> a\) Do not use if you are allergic to omeprazole.

b)  Notify your doctor if you have had heartburn for three months or
    longer and have not talked to your doctor about it.

c)  Do not use if you have trouble swallowing food, wheezing, a chronic
    cough or hoarseness, have vomited blood, black/tarry stools, chest
    pain, or unexplained weight loss.

d)  Do not use if you have a sudden increase of your heartburn symptoms
    with nausea and vomiting; chest pain; pain spreading to your arms,
    neck or shoulders; sweating; shortness of breath or lightheadedness.

e)  Do not use with other acid reducers.

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3)  Consumers understand under what conditions one must first ask their
    doctor or pharmacist before using Prilosec 1 (warnings).

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a)  Ask a doctor or pharmacist before use if you are taking warfarin,
    phenytoin, diazepam, clarithromycin, itraconazole and/or
    ketoconazole.

b)  If pregnant or breast-feeding, ask a health professional before use.

c)  Children under 18 years of age: ask a doctor.

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4)  Consumers understand the condition under which Prilosec 1 can and
    cannot be used (warnings).

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```
a)  Stop use and ask a doctor if stomach pain continues or worsens.

b)  Stop use and ask a doctor if heartburn continues or returns after
    using this product everyday for 14 days.

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```
5)  Consumers understand how to use Prilosec 1 safely and effectively
    (directions).

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```
a)  For prevention of frequent heartburn, swallow 1 tablet with a glass
    of water in the morning.

b)  Take every day for 14 days.

c)  Do not continue beyond 14 days unless directed by your doctor.

d)  Do not take more than 1 tablet a day.

# Methodology

## Participants

There were five cohorts of adult males and females, 18 years of age and
older.

1)  General population adults (n=297)

2)  High literate frequent heartburn sufferers (n=155)

-   above 8^th^ grade reading level

-   experience heartburn 2 or more days a week or currently take
    prescription heartburn medication

3)  Low literate frequent heartburn sufferers (n=162)

-   8^th^ grade reading level or lower

-   experience heartburn 2 or more days a week or currently take
    prescription heartburn medication

4)  Drug interaction heartburn sufferers (n=96)

-   currently experience heartburn, have experienced it in the past 6
    months, or currently take prescription heartburn medication

-   currently take warfarin, phenytoin, diazepam, clarithromycin,
    itraconazole, and/or ketoconazole

-   have no condition listed on the label that would prevent them from
    using the product or that would require them to consult a doctor or
    pharmacist before use, other than the drug interaction

5)  Pregnant/Nursing heartburn sufferers (n=42)

-   currently experience heartburn, have experienced it in the past 6
    months, or currently take prescription heartburn medication

-   pregnant or nursing

-   have no condition listed on the label that would prevent them from
    using the product or that would require them to consult a doctor or
    pharmacist before use, other than pregnancy or nursing

## Procedure

Most participants were recruited in ten geographically dispersed
shopping malls around the country. Participants recruited in malls were
screened for qualifications. Those who qualified were taken to a
facility in the mall and were interviewed. The majority of the drug
interaction heartburn sufferers (Cohort 4) were recruited using
advertising, screened by telephone, and asked to come to a central
location for the interview. The pregnant and nursing heartburn sufferers
(Cohort 5) were recruited primarily by telephone using agency databases,
and were asked to come to a central location for the interview.

All who qualified were given the Rapid Estimate of Adult Literacy in
Medicine (REALM) literacy test. They then examined the label before they
were asked questions about it. Non-sufferers were not asked all the
questions. They were asked only about the purpose of the product,
whether they could use it themselves, and they provided demographic and
medical information relevant to product use. Pregnant or nursing
participants were asked only about product use, whether they could use
it themselves, and questions about use by pregnant and nursing women.
They also provided demographic and medical information relevant to using
the product. All others answered the full questionnaire. All had the
label available to examine during questioning.

There were two different versions of the full questionnaire. Half of the
drug interaction scenarios and half of the heartburn warning symptom
questions were presented in each version to reduce the length of the
questionnaire.

## Recruitment Advertisement and Screening Questionnaire

*Comments.* An advertisement was used to recruit Cohort 4, the heartburn
sufferers who are currently taking prescription medications listed on
the label as requiring physician input. This advertisement listed only
those classes of medications listed in the label. It is possible that
the information in the advertisement, by not including other "false"
medication classes, may have alerted consumers to the possibility that
certain types of medications were important to the study. This may have
biased the results by making participants' medications more salient to
them as factors in the study, making it more likely they would answer
questions about their own use of the product correctly. It would have
been better to use a longer list of drug classes or to make a more
general statement about taking any prescription medicines, or to say
nothing about medicines. If nothing was on the advertisement about
medicines, along with other questions, callers could have been asked if
they took any medicines, to divert them from the true purpose of the
questioning. This would not have given them specific clues about what
the study was interested in, as the actual advertisement did.

## Main Questionnaire

*Comments.* In the series of scenario questions (beginning with Q.2)
about use for episodic heartburn, five questions should be answered "no"
and only two "yes." It would have been better to have a more even
balance so participants would not develop a nay-saying bias based on the
pattern of questions. At some point, participants might realize that
most questions should be answered "no." This feature of the questioning
may be a possible source of bias. It is good practice to have more
balance in such a series.

Q. 13 was asked only of the drug interaction cohort (Cohort 4). If, in
response to the self-selection question (Q. 11), these participants
answered incorrectly that they could use the product, they were asked Q.
13 in which they were provided with a list of contraindicated drugs with
their brand and generic names to help them respond. This question is
troublesome for two reasons. First, consumers in retail settings would
not be given a card with the contraindicated medications on it before
examining the label. Second, both the generic and brand names are
provided. In normal use, consumers would have to depend on their
knowledge of their own medications to determine if they take a
contraindicated medication. They would not have a reference list giving
them the generic names for contraindicated products they might take. The
results of Q. 13 are therefore of dubious value.

When scenario questions were answered incorrectly, participants were
asked to give a reason for their response. It would have been better to
ask the basis for all responses for two reasons. First, participants'
reasons for giving the correct response may not be based on the label,
and second, participants may notice that they are not always asked why
they responded as they did. They may correctly conclude that the quality
of their responses drives the interviewer's decision to ask for a
reason, and this may provide them feedback that would affect the
questioning process.

A series of 11 questions in a row (Q.15-Q.35) contains only one that
should be answered affirmatively and ten that should not. This may have
established a nay-saying bias that would make it more likely that
responses would be correct. Correct responses may therefore be
artificially inflated.

In the next series, a group of seven questions (Q.42-Q.50), all require
that the person see a doctor or not use the product. A nay-saying bias
could have affected these results, providing for more correct responses
than would be the case if there were more balanced responses required.

# Results and Discussion 

Open-ended questions were scored as correct, acceptable, or incorrect.
Correct responses were those that were correct initially or in a
follow-up probe. Responses were acceptable if they did not reflect
information on the label, but would not be incorrect product usage, such
as asking a doctor when it is not necessary.

**Product Purpose.** In general, participants did not give full
responses to the question about the purpose for product use. They either
left out the idea of prevention or the idea of the necessity for
frequent heartburn. When asked what the product is to be used for, only
39% of the general population responded with "prevent frequent
heartburn. The literate frequent sufferers answered this question
correctly 39% of the time, and the low literate frequent sufferers 36%
of the time. Almost everyone else gave a partial response, even after
probing, with answers such as "heartburn," "prevent heartburn," and
"frequent heartburn."

Table 1. Responses to question about purpose of product.

+----------------------+------------+----------------+-----------------+
| **Purpose**          | **General  | **Literate     | **Low Literate  |
|                      | Po         | Frequent       | Frequent        |
|                      | pulation** | Sufferers**    | Sufferers** (%) |
|                      | (%) n=297  | (%) n=155      | n=162           |
+----------------------+------------+----------------+-----------------+
| Complete:            | 39         | 39             | 36              |
|                      |            |                |                 |
| Prevent frequent     |            |                |                 |
|                      |            |                |                 |
| HB                   |            |                |                 |
+----------------------+------------+----------------+-----------------+
| Incomplete:          | 40         | 45\*           | 24              |
|                      |            |                |                 |
| Heartburn            |            |                |                 |
+----------------------+------------+----------------+-----------------+
| Prevent HB           | 6          | 4              | 20\*            |
+----------------------+------------+----------------+-----------------+
| Frequent or 2+       | 13         | 10             | 18              |
|                      |            |                |                 |
| days/week HB         |            |                |                 |
+----------------------+------------+----------------+-----------------+
| Acid reflux          | 2          | 2              | 2               |
+----------------------+------------+----------------+-----------------+

\*statistically significant difference between literacy groups at 95%
confidence level

Questions about use for relief or prevention of heartburn episodes
resulted in low proportions of correct responses. Approximately half of
the general population believed the product was appropriate for relief
and prevention of individual heartburn episodes. For three of the five
questions in this area, the frequent sufferers, low and higher literacy,
responded in the low to mid-sixty percent. Responses to this question
indicate the label did not communicate the prevention message
adequately. If there were no nay-saying response bias for this series of
questions (discussed earlier), scores may have been even lower. These
were all questions for which a correct response was that the product
should not be used. Many participants seemed not to understand not to
use the product episodically or for relief.

Table 2. Correct responses to episodic heartburn questions.

+--------+--------+-----------------+-----------------+-----------------+
| **Q.** | **Epis | **General       | **Literate      | **Low Literate  |
|        | odic** | Population**    | Freq.           | Freq.           |
|        |        | (%)             | Sufferers** (%) | Sufferers** (%) |
|        |        |                 | n=155           | n=162           |
|        |        | n=297           |                 |                 |
+--------+--------+-----------------+-----------------+-----------------+
| 2      | relief | 55              | 61\*            | 49              |
+--------+--------+-----------------+-----------------+-----------------+
| 3      | relief | 52              | 67              | 66              |
+--------+--------+-----------------+-----------------+-----------------+
| 5      | relief | 48              | 51              | 59              |
|        | in     |                 |                 |                 |
|        | freq.  |                 |                 |                 |
|        | su     |                 |                 |                 |
|        | fferer |                 |                 |                 |
+--------+--------+-----------------+-----------------+-----------------+
| 6      | p      | 54              | 57              | 63              |
|        | revent |                 |                 |                 |
+--------+--------+-----------------+-----------------+-----------------+
| 8      | p      | 61              | 65              | 65              |
|        | revent |                 |                 |                 |
+--------+--------+-----------------+-----------------+-----------------+

\*statistically significant difference between literacy groups at 95%
confidence level

For two questions about using the product to prevent frequent heartburn,
responses were generally above 80-90%. These were the two questions for
which the correct response was that it was appropriate to use the
product.

Table 3. Correct responses to frequent heartburn questions.

+--------+---------+---------------+-----------------+-----------------+
| **Q.** | **Fre   | **General     | **Literate      | **Low Literate  |
|        | quent** | Population**  | Freq.           | Freq.           |
|        |         | (%)           | Sufferers** (%) | Sufferers** (%) |
|        |         |               | n=155           | n=162           |
|        |         | n=297         |                 |                 |
+--------+---------+---------------+-----------------+-----------------+
| 4      | prevent | 93            | 94\*            | 79              |
+--------+---------+---------------+-----------------+-----------------+
| 7      | prevent | 83            | 87              | 83              |
+--------+---------+---------------+-----------------+-----------------+

\*statistically significant difference between literacy groups at 95%
confidence level

**Self-selection.** When asked if they, themselves, could use the
product, the range of correct responses in the group that should not use
the product or should consult a physician varied from 41% to 91%. Of the
total, 67% were correct overall. For one group, frequent heartburn
sufferers with contraindicated medication, scores rose from 50% to 86%
after seeing a list of the brand names of the drugs they use. However,
in a purchase situation, these types of consumers would be unlikely to
have access to a list of the brand and corresponding generic names.
Thus, the 50% score is probably more representative of the types of
decisions they would be likely to make based on the label. The highest
scoring group was those who were allergic. There were only seven members
of this group, so the results may not be representative. It is important
to note that those who have contraindicated symptoms or who took
contraindicated medication selected for themselves incorrectly at least
50% of the time.

Table 4. Responses to self-selection questions for those who should not
use

(Q9-14)

+------------------------------+-----------------------+---------------+
| **Participant                | *                     | **Incorrect** |
| Characteristics**            | *Correct/Acceptable** | (%)           |
|                              | (%)                   |               |
+------------------------------+-----------------------+---------------+
| Total (n=459)                | 67                    | 33            |
+------------------------------+-----------------------+---------------+
| Non HB sufferer (n=137)      | 80                    | 20            |
+------------------------------+-----------------------+---------------+
| Infrequent HB sufferer n=92  | 76                    | 24            |
+------------------------------+-----------------------+---------------+
| Frequent HB sufferer         | 86                    | 14            |
| allergic to omeprazole(n=7)  |                       |               |
+------------------------------+-----------------------+---------------+
| Frequent HB sufferer with    | 41                    | 59            |
| contraindicated symptom      |                       |               |
| (n=85)                       |                       |               |
+------------------------------+-----------------------+---------------+
| Frequent HB sufferer with    | 50                    | 50            |
| contraindicated medication   |                       |               |
| (n=96)                       | 82                    | 18            |
|                              |                       |               |
| After see brand names        |                       |               |
+------------------------------+-----------------------+---------------+
| HB sufferers and pregnant or | 91                    | 10            |
| nursing (n=42)               |                       |               |
+------------------------------+-----------------------+---------------+

**Use with health conditions.** Responses to scenario questions about
whether individuals with particular health conditions could take the
product were generally good, ranging from 89%-91% in the general
population, and from 90% to 100% in the two literacy groups. However,
these questions were in a series that could have established a
nay-saying bias, as mentioned earlier. These high scores may have been
due, in part, to participants' realizing that almost every response
should be not to use the product or to see a doctor.

Table 5. Correct/acceptable responses to scenarios about taking product
with different conditions

+--------+------------+------------+-----------------+-----------------+
| **Q.** | ###        | **General  | **Literate      | **Low Literate  |
|        |  Condition | Pop** (%)  | Freq.           | Freq.           |
|        |            |            | Sufferers** (%) | Sufferers** (%) |
|        |            | (base n)   |                 |                 |
|        |            |            | (base n)        | (base n)        |
+--------+------------+------------+-----------------+-----------------+
| 15     | Allergic   | 91 (158)   | 92 (155)        | 94 (162)        |
+--------+------------+------------+-----------------+-----------------+
| 17     | Heartburn  | 89 (160)   | 95 (155)        | 95 (162)        |
|        | 6 months;  |            |                 |                 |
|        | no doctor  |            |                 |                 |
+--------+------------+------------+-----------------+-----------------+
| 18/19  | trouble    | 89 (83)    | 90 (79)         | 95 (109)        |
|        | swallowing |            |                 |                 |
+--------+------------+------------+-----------------+-----------------+
| 20/21  | chest      | 94 (83)    | 96 (79)         | 95 (109)        |
|        | pain, pain |            |                 |                 |
|        | spreading  |            |                 |                 |
|        | to arms    |            |                 |                 |
|        | and        |            |                 |                 |
|        | shoulders, |            |                 |                 |
|        | shortness  |            |                 |                 |
|        | of breath  |            |                 |                 |
+--------+------------+------------+-----------------+-----------------+
| 22/23  | chronic    | 89 (75)    | 93 (76)         | 94 (53)         |
|        | cough      |            |                 |                 |
+--------+------------+------------+-----------------+-----------------+
| 24     | black      | 98 (83)    | 99 (79)         | 99 (109)        |
|        | tarry      |            |                 |                 |
|        | stools     |            |                 |                 |
+--------+------------+------------+-----------------+-----------------+
| 25     | u          | 96 (75)    | 97 (76)         | 100 (53)        |
|        | nexplained |            |                 |                 |
|        | weight     |            |                 |                 |
|        | loss       |            |                 |                 |
+--------+------------+------------+-----------------+-----------------+
| 27     | heartburn  | 98 (158)   | 98 (155)        | 96 (162)        |
|        | worse;     |            |                 |                 |
|        | nausea,    |            |                 |                 |
|        | vomiting   |            |                 |                 |
+--------+------------+------------+-----------------+-----------------+

There were very high percentages of correct responses to questions about
use by pregnant and nursing women and by children. Again, these
questions were in a nay-saying series.

Table 6. Use with pregnancy, nursing, children

+--------+-----------+-------------+-----------------+-----------------+
| **Q.** | **con     | **General   | **Literate      | **Low Literate  |
|        | dition/** | Pop** (%)   | Freq.           | Freq.           |
|        |           |             | Sufferers** (%) | Sufferers** (%) |
|        | *         | (base n)    |                 |                 |
|        | *status** |             | (base n)        | (base n)        |
+--------+-----------+-------------+-----------------+-----------------+
| 48     | breas     | 99 (90)     | 100 (81)        | 98 (86)         |
|        | t-feeding |             |                 |                 |
+--------+-----------+-------------+-----------------+-----------------+
| 49     | pregnant  | 98 (90)     | 100 (81)        | 99 (86)         |
+--------+-----------+-------------+-----------------+-----------------+
| 50     | age 15    | 96 (158)    | 99 (155)        | 96 (162)        |
+--------+-----------+-------------+-----------------+-----------------+

**Use with other products.** Correct responses to questions about use
with other products were generally very high, ranging from 91-100%. for
some of these products, consumers should consult a physician or
pharmacist before using Prilosec 1.

Table 7. Use with other products

+------+------------+-------------+-----------------+-----------------+
| **   | #          | **General   | **Literate      | **Low Literate  |
| Q.** | ## Product | P           | Freq.**         | Freq.           |
|      |            | opulation** |                 | Sufferers** (%) |
|      |            | (%)         | **Sufferers**   |                 |
|      |            |             | (%)             | (base n)        |
|      |            | (base n)    |                 |                 |
|      |            |             | (base n)        |                 |
+------+------------+-------------+-----------------+-----------------+
| 2    | other acid | 91 (158)    | 89 (155)        | 97\* (162)      |
| 8/29 | reducers   |             |                 |                 |
+------+------------+-------------+-----------------+-----------------+
| 30   | warfarin   | 98 (83)     | 99 (79)         | 98 (98)         |
+------+------------+-------------+-----------------+-----------------+
| 31   | phenytoin  | 100 (75)    | 100 (76)        | 98 (53)         |
+------+------------+-------------+-----------------+-----------------+
| 34   | diazepam   | 98 (83)     | 98 (79)         | 99 (109)        |
+------+------------+-------------+-----------------+-----------------+
| 37   | antibiotic | 99 (75)     | 97 (76)         | 98 (53)         |
|      | clar       |             |                 |                 |
|      | ithromycin |             |                 |                 |
+------+------------+-------------+-----------------+-----------------+
| 42   | it         | 98 (42)     | 99 (79)         | 98 (109)        |
|      | raconazole |             |                 |                 |
+------+------------+-------------+-----------------+-----------------+
| 43   | ke         | 97 (75)     | 100 (76)        | 100 (53)        |
|      | toconazole |             |                 |                 |
+------+------------+-------------+-----------------+-----------------+
| 3    | Tylenol    | 93 (158)    | 97 (155)        | 93 (162)        |
| 5/36 |            |             |                 |                 |
+------+------------+-------------+-----------------+-----------------+

\*statistically significant difference between literacy groups at 95%
confidence level

There seemed to be very good scores for what actions to take while using
the product, including when to stop taking it, how long to use it, and
when and how much to dose. However, some of these questions (33, 44, 46,
47) were in a nay-saying series.

Table 8. Actions During Use

+----+--------------+-------------+-----------------+-----------------+
| ** | *            | **General   | **Literate      | **Low Literate  |
| Q. | *Situation** | Pop         | Freq. Sufferers | Freq. Sufferers |
| ** |              | Correct/**  | Corre           | Corre           |
|    |              |             | ct/Acceptable** | ct/Acceptable** |
|    |              | **A         | (%) (base n)    | (%) (base n)    |
|    |              | cceptable** |                 |                 |
|    |              | (%)         |                 |                 |
|    |              |             |                 |                 |
|    |              | (base n)    |                 |                 |
+----+--------------+-------------+-----------------+-----------------+
| 44 | stomach pain | 100 (158)   | 100 (155)       | 100 (162)       |
|    | worse        |             |                 |                 |
+----+--------------+-------------+-----------------+-----------------+
| 47 | more than 14 | 96 (158)    | 96 (155)        | 96 (162)        |
|    | days         |             |                 |                 |
+----+--------------+-------------+-----------------+-----------------+
| 33 | more than 14 | 89 (158)    | 94 (155)        | 93 (162)        |
|    | days         |             |                 |                 |
+----+--------------+-------------+-----------------+-----------------+
| 38 | time to take | 85 (158)    | 88 (155)        | 83 (162)        |
|    | dose         |             |                 |                 |
+----+--------------+-------------+-----------------+-----------------+
| 39 | \# tablets   | 98 (158)    | 99\* 155)       | 89 (162)        |
|    | daily        |             |                 |                 |
+----+--------------+-------------+-----------------+-----------------+
| 46 | take an      | 97 (158)    | 98 (155)        | 94 (162)        |
|    | extra for    |             |                 |                 |
|    | episodic     |             |                 |                 |
|    | prevention   |             |                 |                 |
+----+--------------+-------------+-----------------+-----------------+
| 40 | dosing       | 98 (158)    | 98 (155)        | 88 (162)        |
|    | frequency    |             |                 |                 |
+----+--------------+-------------+-----------------+-----------------+
| 41 | how long     | 94 (158)    | 95\* (155)      | 82 (162)        |
|    | take         |             |                 |                 |
+----+--------------+-------------+-----------------+-----------------+

\*statistically significant difference between literacy groups at 95%
confidence level

Because this questionnaire overwhelmingly contained questions that
required responses that the product should not be used or that a doctor
or pharmacist should be consulted, a strong nay-saying bias may have
been responsible for the very high scores in these series. Thus, the
scores are of questionable reliability and validity. It would have been
much better to have more questions that did not preclude taking the
medication or taking the other action that was mentioned in some of the
questions.

# Conclusion and comparison of tested label with proposed label

These results suggest that the tested label does not adequately convey
to consumers the following:

-   the product is not for episodic use and

-   the product is only for prevention

Based on results of the self-selection question, it is not clear
consumers will understand that the product should not be used with
certain other medications or with certain health conditions unless one
checks with a doctor or pharmacist.

Some of the high levels of correct responses to the scenario questions
may have been due to an artifact of the questioning by which almost all
questions required responses that the product should not be used or a
health professional should be consulted.

If one compares the tested label with the proposed label for these areas
of sub-optimal communication, one finds that there has been little or no
change to the label to improve communication of some of these messages.
In the proposed label, the prevention message is the same, with added
wording about preventing symptoms and 24 hour coverage. The tested label
says "for **prevention** of frequent heartburn." The proposed label says
"for **prevention** of the symptoms of frequent heartburn for 24 hours."
There is nothing on either label to indicate that episodic use is
inappropriate, other than the directions to use it every day for 14
days. This message is the same on the tested and proposed labels.

The proposed label lists only three products that require consultation
with a health professional, while the tested label had six. The section
in the tested label that said "Do not use" contained lists of multiple
conditions under two bullets that require the person consult a
physician. In the proposed label, these are broken into five bullets,
which may be easier to read and to process cognitively.

The "do not use" section of the tested label has been changed to "Ask a
doctor before use if you have" in the proposed label. Furthermore, some
conditions in the tested label are not in the proposed label. These
include chronic cough or hoarseness, vomiting blood, black tarry stools,
and sudden increase in symptoms with nausea and vomiting. The proposed
label has five bullets in this section, while the tested label had only
three covering more conditions. The resultant label section in the
proposed label is shorter and easier to read and process. However, it
has not strengthened the message about prevention or that it is not for
episodic use. It is improved regarding use with other medicines because
that section is shorter. It is improved regarding use with certain
medical conditions because that section is shorter and has more bullets.

Testing of the proposed label is necessary to conclude whether it
communicates better than the tested label in critical areas.