Guidance for Industry 

Dosage Delivery Devices for 

OTC Liquid Drug Products 

DRAFT GUIDANCE 

This guidance document is being distributed for comment purposes only. 

Comments and suggestions regarding this draft document should be submitted within 90 days of 

publication in the Federal Register of the notice announcing the availability of the draft 

guidance. Submit comments to the Division of Dockets Management (HFA-305), Food and 

Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments 

should be identified with the docket number listed in the notice of availability that publishes in 

the Federal Register. 

For questions regarding this draft document contact Spencer Salis at 301-796-3327. 

U.S. Department of Health and Human Services 

Food and Drug Administration 

Center for Drug Evaluation and Research (CDER) 

November 2009 

Compliance 

8352dft.doc 
Guidance for Industry 

Dosage Delivery Devices for 

OTC Liquid Drug Products 

Additional copies are available from: 

Office of Training and Communications
 

Division of Communications Management
 

Division of Drug Information
 

Center for Drug Evaluation and Research
 

Food and Drug Administration 

10903 New Hampshire Ave., Bldg. 51, rm. 2201
 

Silver Spring, MD 20993-000 

301-796-3400 

Internet: http://www.fda.gov/cder/guidance/index.htm 

U.S. Department of Health and Human Services 

Food and Drug Administration 

Center for Drug Evaluation and Research (CDER) 

November 2009 

Compliance 

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TABLE OF CONTENTS 

I. INTRODUCTION............................................................................................................. 1
 

II. BACKGROUND ............................................................................................................... 2
 

III. REGULATORY/POLICY DISCUSSION...................................................................... 2
 

A. Statutory Requirements and Regulatory History .......................................................................2
 

B. Recommendations..........................................................................................................................3
 

APPENDIX A: EXAMPLES OF DOSAGE CUPS THAT DO NOT CORRESPOND TO 

DOSING DIRECTIONS .............................................................................................................. 6
 

APPENDIX B: EXAMPLE OF DOSAGE CUP THAT CORRESPONDS TO DOSING 

DIRECTIONS ............................................................................................................................. 10
 

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Contains Nonbinding Recommendations 

Draft—Not for Implementation
 

1 Guidance for Industry1
 

2 

3 Dosage Delivery Devices for OTC Liquid Drug Products
 4 

5 

6 

7 

8 This draft guidance, once finalized, will represent the Food and Drug Administration's (FDA's) current 

9 thinking on this topic. It does not create or confer any rights for or on any person and does not operate to 

10 bind FDA or the public. You may use an alternative approach if it satisfies the requirements of the 

11 applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff 

12 responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the 

13 appropriate number listed on the title page of this guidance. 

14 

15 

16 

17 I. INTRODUCTION 

18 

19 This document is intended to provide guidance to firms that are manufacturing, marketing, or 

20 distributing over-the-counter (OTC) liquid drug products (e.g., elixirs, suspensions, solutions, 

21 syrups) that are packaged with dosage delivery devices (e.g., calibrated cups, droppers, syringes, 

22 spoons).2 Because written, printed, or graphic matter appearing on dosage delivery devices 

23 packaged with OTC liquid drug products is considered labeling, such markings on these devices 

24 must not be false or misleading and must be clear and consistent with the drug product’s 

25 directions for use. (See Sections 201(m), 502(a) and 502(f)(1) of the Federal Food, Drug, and 

26 Cosmetic Act). 

27 

28 FDA's guidance documents, including this guidance, do not establish legally enforceable 

29 responsibilities. Instead, guidance documents describe the Agency's current thinking on a topic 

30 and should be viewed only as recommendations, unless specific regulatory or statutory 

31 requirements are cited. The use of the word should in Agency guidances means that something 

32 is suggested or recommended, but not required. 

33 

34 

35 

36 

1

 This guidance has been prepared by the Center for Drug Evaluation and Research (CDER) at the Food and Drug 

Administration. 

2

 This guidance is not intended to address the adequacy of dosage delivery devices to deliver the labeled dosage. It 

is the responsibility of the manufacturers, packers, and distributors of these liquid drug products packaged with 

dosage delivery devices to ensure that the accompanying dosage delivery devices accurately deliver the doses 

identified by the measurements. FDA may issue additional guidance regarding the adequacy of dosage delivery 

devices to deliver the labeled dosage and to ensure that consumers can properly use dosage delivery devices that 

accompany OTC liquid drug products. 

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37 II. BACKGROUND 

38 

39 Many OTC liquid drug products are packaged with dosage delivery devices intended to facilitate 

40 proper dispensing of the product by the patient, parent, or caregiver. In most cases, these devices 

41 have calibrated units of measure marked on the device (e.g., teaspoon, tablespoon, or milliliter) 

42 that are intended to ensure proper measurement of the appropriate dose. However, in many 

43 cases, OTC liquid drug products in the marketplace are packaged with dosage delivery devices 

44 that bear markings that are inconsistent with the labeled dosage directions. For example, some 

45 may contain superfluous markings or may be missing necessary markings. The Agency also is 

46 aware that some people typically do not use dosage delivery devices provided with OTC drug 

47 products, and consumers have reported some difficulties measuring OTC liquid medications for 

48 their children with provided dosage delivery devices. These difficulties may lead to consumers 

49 using less accurate means to give their children analgesics, cough and cold, and other common 

50 OTC liquid medications, e.g., household spoons. 

51 

52 There have been numerous reports of accidental overdose that were attributed, in part, to 

53 markings on measured dosage cups for OTC liquid drug products that were misleading or 

54 incompatible with the labeled dosage directions for use. 

55 

56 FDA is issuing this guidance because of ongoing safety concerns about the serious potential for 

57 accidental drug overdoses of OTC liquid drug products that can result from the use of dosage 

58 delivery devices with markings that are inconsistent or incompatible with the labeled dosage 

59 directions for OTC drug products. FDA is especially concerned because OTC liquid drug 

60 products are frequently intended to be used with pediatric populations. 

61 

62 

63 III. REGULATORY/POLICY DISCUSSION 

64 

65 A. Statutory Requirements and Regulatory History 

66 

67 Section 502 of the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C 352) states that a 

68 drug is considered to be misbranded: 

69 

70 (a) if its labeling is false or misleading in any particular [or] . . . 

71 (f) unless its labeling bears (1) adequate directions for use . . . . 

72 

73 Section 201(m) of the FFDCA further defines labeling as “all labels and other written, printed, or 

74 graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying 

75 such article” (21 U.S.C 321(m)). The Agency considers any written, printed, or graphic matter, 

76 including measurements on dosage delivery devices, packaged with OTC liquid drug products to 

77 be labeling. FDA has issued notices and Warning Letters that cite misbranding violations under 

78 section 502(a) of the FFDCA (21 U.S.C. 352(a)) when markings on dosage delivery devices are 

79 inconsistent with the labeled dosage directions. Examples include the following: 

80 

81 • On December 9, 1991, FDA issued a Compliance Notice to alert all drug establishments that 

82 were registered with the Agency to review the labeling of all drug products marketed with an 

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83 accompanying dosage delivery device to determine if the product’s labeling was compatible 

84 with the markings on the dosage device, and make corrections where necessary. 

85 

86 In this notice, FDA said that dosage delivery devices that had markings inconsistent with the 

87 product’s labeling rendered the drug product misbranded under 21 U.S.C. 352(a). 

88 

89 • On January 21, 1992, FDA issued a Public Health Announcement warning parents against 

90 the inadvertent overdosing of children with liquid OTC medications for colds and flu. 

91 • Between November 1991 and January 1992, FDA issued Warning Letters to five firms that 

92 were marketing OTC liquid drug products with dosage delivery devices that were not 

93 compatible with the products’ labeled dosage directions. Those letters cited violations of 

94 section 502(a) of the FFDCA (21 U.S.C. 352(a)) because the markings on the dosage cups 

95 packaged with the products were misleading within the context of the labeled directions for 

96 use. Additionally, eight firms initiated recalls of over 980,000 retail units nationwide of 

97 OTC oral liquid drug products that had misleading or incompatible dosage delivery devices 

98 during the same time period. Since January 1992, several other firms have conducted large99 scale recalls of OTC oral liquid drug products with misleading or incompatible dosage 

100 delivery devices. 

101 • On January 17, 2008, FDA issued a Public Health Advisory recommending that when giving 

102 OTC cough and cold medicines to children ages two years and older, parents and caregivers 

103 use only the measuring spoons or cups that come with the medicine or those made specially 

104 for measuring drugs. 

105 Despite these efforts, through routine monitoring and surveillance programs, FDA has become 

106 aware that an increasing number of OTC liquid drug products have dosage delivery devices that 

107 are incompatible with labeled product dosage directions. 

108 

109 In addition to misbranding under section 502(a) of the FFDCA (21 U.S.C. 352(a)), when dosage 

110 delivery devices packaged with OTC liquid drug products fail to bear a mark or markings 

111 consistent with the labeled dosage directions, the products also lack adequate directions for use 

112 and are misbranded under section 502(f)(1) of the FFDCA (21 U.S.C. 352(f)(1)). 

113 

114 B. Recommendations 

115 

116 The Agency makes the following recommendations for OTC liquid drug products: 

117 

118 • Dosage delivery devices should be included for all OTC drug products that are liquid 

119 formulations. 

120 • These devices should have calibrated units of measure marked on the device (e.g. teaspoon, 

121 tablespoon, or milliliter) that are the same as the units of measure specified in the labeled 

122 dosage directions on any outside packaging (carton labeling), bottle, and any accompanying 

123 written instructions. 

124 • If units of measure are abbreviated on the dosage delivery device, the abbreviation used on 

125 the device should be the same abbreviation used in the labeled dosage directions, outside 

126 packaging (carton labeling), bottle, and any accompanying written instructions. 

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127 - International or national standards for abbreviations should be used. For example, 

128 milliliters should be abbreviated as “mL” and teaspoons abbreviated as “tsp,” and less 

129 common or nonstandard used abbreviations should be avoided. 

130 - Abbreviations should be defined on the dosing device (e.g., tsp = teaspoon) and, if 

131 they are not, should be defined in the labeled dosage directions, outside packaging 

132 (carton labeling), bottle, and any accompanying written instructions. 

133 • Any decimals or fractions included on dosage delivery devices should be listed as clearly as 

134 possible. 

135 − Use leading zeroes before decimal points (“0.4” not “.4”) to avoid 10-fold dosing 

136 errors. 

137 − Use smaller font size for numerals in fractions (“1⁄2” not “1/2”) to avoid interpreting 

138 “1/2" as “1 or 2.” 

139 • Dosage delivery devices should not bear extraneous or unnecessary markings that may be 

140 confusing. 

141 • Manufactures should try to ensure that the dosage delivery devices are used only with the 

142 products with which they are included. Possible ways of accomplishing this are to either: 

143 – Include a statement on the dosage delivery device and the drug product’s bottle 

144 and/or carton labeling that only the provided dosage delivery device is to be used with 

145 the particular OTC drug product with which it is included. This information can also 

146 be included under the Directions Section of the product’s Drug Facts panel 

147 – Devise a mechanism to secure the dosage delivery device to the drug product, such as 

148 creating an integrated dosing device. 

149 • Dosage delivery devices should not be significantly larger than the largest dose described 

150 in the labeled dosage directions and should permit clear measurement and delivery of the 

151 smallest labeled dosage.3 

152 • The markings on dosage delivery devices should be clearly visible and not be obscured when 

153 the product is added to the device. 

154 The Agency also recommends that firms conduct usability studies to ensure that dosage delivery 

155 devices are easily understood and accurately used by consumers.4 

156 

157 Because the Agency regards the markings on these delivery devices as labeling, FDA considers 

158 their failure to bear markings consistent with the labeled dosage directions to cause the drug 

159 product to be misbranded. For example, if the bottle and/or carton labeling for a drug product 

160 contains dosage directions that are written exclusively in terms of a specific unit of measure, the 

161 accompanying dosage delivery device should contain markings in the same unit of measure. The 

162 following examples illustrate situations that would render the products misbranded: 

3

 For concentrated acetaminophen infant drops, the Agency recommends that dosage delivery devices should also
 

permit clear measurement and delivery of the smallest intended dosage consistent with professional labeling for
 

infants under 2 years of age.

4

 Although this Guidance is not intended to address the adequacy of dosage delivery devices to deliver the labeled 

dosage, the Agency may consider issuing future guidance to industry that addresses topics such as: age, weight, 

solubility, viscosity, patient populations, and instructions for cleaning, reuse, and storage. 

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163 

164 Example 1: The directions for use on the bottle and/or carton specify teaspoon measures 

165 to describe the dosing amount; the dosage cup that is supplied with the product bears 

166 three different graduated scales (one is a combined scale of 

167 teaspoonfuls/dessertspoonfuls/tablespoonfuls; the second provides metric measurements 

168 (cc/ml); and, the third is a combined scale of fluid ounces and drams) (see Appendix A, 

169 Illustration #l). 

170 

171 Example 2: The directions for use on the bottle and/or carton specify teaspoon measures 

172 to describe the dosing amount; the dosage cup provided with the product bears two 

173 different graduated scales (one is a combined scale of teaspoonfuls/tablespoonfuls with 

174 juxtaposed conversions to milliliters (Note: the illustration also has a dessertspoon 

175 marking); the second is a combined scale of milliliters and fluid ounces) (see Appendix 

176 A, Illustration #2). 

177 

178 The Agency also recommends that the dosage delivery device for a drug product provide 

179 markings that can readily measure the dosage indicated by the directions on the bottle and/or 

180 carton labeling. Again, the following examples illustrate situations that would render the 

181 products misbranded: 

182 

183 Example 3: The directions for use on the drug product’s bottle and/or carton specify a 2­

184 teaspoonful dose (see Appendix A, Illustration #3); the dosage cup does not bear a 

185 corresponding 2-teaspoonful graduation (See Appendix A, Illustration #1). 

186 

187 Example 4: The directions for use on the drug product’s bottle and/or carton specify 1/2­

188 teaspoonful dose (see Appendix A, Illustration #3); the dosage cup does not bear a 

189 corresponding 1⁄2-teaspoonful graduation (see Appendix A, Illustration #4). 

190 

191 In addition to the scenarios described above, FDA is concerned about products that include a 

192 dosage delivery device and provide directions for use that state: 

193 

194 Under 2 [or 6, etc.] years of age: consult a physician 

195 

196 The Agency recommends that the labeling for these types of products include a prominent 

197 statement that directs consumers to consult their pharmacist or healthcare provider for any 

198 appropriate additional dosage delivery device necessary for use when a physician recommends a 

199 dose that is different than the doses that appear on the dosage delivery device that accompanies 

200 the product. 

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Contains Nonbinding Recommendations 

Draft—Not for Implementation 

201 

202 

203 

204 

205 

206 

207 

APPENDIX A: EXAMPLES OF DOSAGE CUPS THAT DO NOT CORRESPOND TO 

DOSING DIRECTIONS 

208 

209 

210 
 

211 

212 

213 

214 

215 

216 

217 

218 

219 

220 

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221 

222 

223 BOTTLE AND/OR CARTON LABELING 

224 

225 

226 

227 

228 

ILLUSTRATION # 3 

I 

Drug Facts (continued) 

Directions • do not take more than 6 doses in any 24 hour period 

• use only with enclosed measuring cup. Do not use with any other device 

• dose as follows 

adults and children 12 years of age and 2 teaspoons every 4 hours 

older 

children 6 to 12 years of age 1 teaspoon every 4 hours 

children 2 years to 6 years of age 1/2 teaspoon every 4 hours. 

children under 2 years of age do not use 

Other information 

• store at 20 - 25oC (68 - 77oF) 

• alcohol free 

Inactive ingredients: (established names of each inactive ingredient listed in 

alphabetic order) 

Questions? call weekdays 9 AM to 5 PM EST at 1-800-XXX- XXXX 

229 

230 

231 

232 

233 

234 

235 

236 

237 

238 

239 

240 

241 

242 

243 

244 

245 

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246 DOSAGE CUP 

247 

248 ILLUSTRATION # 4 

249 

250 

251 

252 

253 

254 

255 

256 

257 

258 

259 

260 

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262 

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264 

265 

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267 

268 

269 

270 

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271 

272 

273 

274 

275 

276 

APPENDIX B: EXAMPLE OF DOSAGE CUP THAT CORRESPONDS TO DOSING 

DIRECTIONS 

The example below illustrates a dosage cup that corresponds to the dosing directions described in 

the drug facts panel below. 

277 

278 BOTTLE AND/OR CARTON LABELING 

279 

280 

Drug Facts (continued) 

Directions • do not take more than 6 doses in any 24 hour period 

• use only with enclosed measuring cup. Do not use with any other device 

• dose as follows 

adults and children 12 years of age and 2 teaspoons (tsp) every 4 hours 

older 

children 6 to 12 years of age 1 teaspoon (tsp) every 4 hours 

children 2 years to 6 years of age 1⁄2 teaspoon (tsp) every 4 hours. 

children under 2 years of age do not use 

Other information 

• store at 20 - 25oC (68 - 77oF) 

• alcohol free 

Inactive ingredients: (established names of each inactive ingredient listed in 

alphabetic order) 

Questions? call weekdays 9 AM to 5 PM EST at 1-800-XXX- XXXX 

281 

282 

283 

284 

285 

286 

287 

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