Acetaminophen (oral solution)

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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

# Overview
Acetaminophen (oral solution) is an analgesic and antipyretic that is FDA approved for the treatment of minor aches and pains due to headache, muscular aches, and backache.   Common adverse reactions include pruritus, constipation, nausea, vomiting, headache, agitation, insomnia, and atelectasis.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)
- Temporarily relieves minor aches and pains due to:
- Headache
- Muscular aches
- Backache
- Minor pain of arthritis
- The common cold
- Toothache
- Premenstrual and menstrual cramps
- Temporarily reduces fever
- Do not take more than directed

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Acetaminophen (oral solution) in adult patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Acetaminophen (oral solution) in adult patients.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Acetaminophen (oral solution) in pediatric patients.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Acetaminophen (oral solution) in pediatric patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Acetaminophen (oral solution) in pediatric patients.

# Contraindications
There is limited information regarding Contraindications of Acetaminophen (oral solution) in pediatric patients.

# Warnings
- Liver warning
- This product contains acetaminophen. Severe liver damage may occur if:
- Adult takes more than 6 doses in 24 hours, which is the maximum daily amount
- Child takes more than 5 doses in 24 hours
- Adult has 3 or more alcoholic drinks everyday while using this product
- Sore throat warning
- If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
- Do not use
- With any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- If you are allergic to acetaminophen or any of the inactive ingredients of this product
- Ask a doctor before use if the user has liver disease.
- Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin.
- Stop use and ask a doctor if
- Pain gets worse or lasts more than 10 days in adults and children
- Pain gets worse or lasts more than 5 days in children under 12 years
- Fever gets worse or lasts more than 3 days
- New symptoms occur
- Redness or swelling is present
- These could be signs of a serious condition.
- Report serious side effects to this phone number: 1-800-845-8210.

# Adverse Reactions

## Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Acetaminophen (oral solution) in the drug label.

## Postmarketing Experience
There is limited information regarding Postmarketing Experience of Acetaminophen (oral solution) in the drug label.

# Drug Interactions
There is limited information regarding Drug Interactions of Acetaminophen (oral solution) in the drug label.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): C
- If pregnant or breast-feeding, ask a health professional before use.
Pregnancy Category (AUS): 
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Acetaminophen (oral solution) in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Acetaminophen (oral solution) during labor and delivery.

### Nursing Mothers
There is no FDA guidance on the use of Acetaminophen (oral solution) with respect to nursing mothers.

### Pediatric Use
- Keep out of reach of children.

### Geriatic Use
There is no FDA guidance on the use of Acetaminophen (oral solution) with respect to geriatric patients.

### Gender
There is no FDA guidance on the use of Acetaminophen (oral solution) with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Acetaminophen (oral solution) with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Acetaminophen (oral solution) in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Acetaminophen (oral solution) in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Acetaminophen (oral solution) in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Acetaminophen (oral solution) in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Oral

### Monitoring
There is limited information regarding Monitoring of Acetaminophen (oral solution) in the drug label.

# IV Compatibility
There is limited information regarding IV Compatibility of Acetaminophen (oral solution) in the drug label.

# Overdosage
- Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

# Pharmacology

## Mechanism of Action
There is limited information regarding Mechanism of Action of Acetaminophen (oral solution) in the drug label.

## Structure

## Pharmacodynamics
There is limited information regarding Pharmacodynamics of Acetaminophen (oral solution) in the drug label.

## Pharmacokinetics
There is limited information regarding Pharmacokinetics of Acetaminophen (oral solution) in the drug label.

## Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Acetaminophen (oral solution) in the drug label.

# Clinical Studies
There is limited information regarding Clinical Studies of Acetaminophen (oral solution) in the drug label.

# How Supplied
- Sodium content: 2 mg/5 mL
- Keep tightly closed
- Protect from light
- A red, cherry flavored solution supplied in the following oral dosage forms:
- NDC 0121-0657-05 (unit dose cups of 5 mL, 10  10's), NDC 0121-0657-11 (unit dose cups of 10.15 mL, 10  10's), and NDC 0121-0657-21 (unit dose cups of 20.3 mL, 10  10's).

## Storage
- Store at 20 to 25C (68 to 77F)

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
There is limited information regarding Patient Counseling Information of Acetaminophen (oral solution) in the drug label.

# Precautions with Alcohol
- Alcohol-Acetaminophen (oral solution) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
Acetaminophen Oral Solution USP

# Look-Alike Drug Names
There is limited information regarding Look-Alike Drug Names of Acetaminophen (oral solution) in the drug label.

# Drug Shortage Status

# Price