Acetaminophen (oral solution)

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Acetaminophen (oral solution)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Aparna Vuppala, M.B.B.S. [2]

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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:
Dosing Information
  • Do not take more than directed
This image is provided by the National Library of Medicine.

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.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-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.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-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

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

Template:Px
Paracetamol (acetaminophen)
Systematic (IUPAC) name
N-(4-hydroxyphenyl)ethanamide
N-(4-hydroxyphenyl)acetamide
Identifiers
CAS number 103-90-2
ATC code N02BE01
PubChem 1983
DrugBank DB00316
Chemical data
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Mol. mass 151.163 g/mol
SMILES eMolecules & PubChem
Physical data
Density 1.263 g/cm³
Melt. point 169 °C (336 °F)
Solubility in water 12.78[1] mg/mL (20 °C)
Pharmacokinetic data
Bioavailability 63-89%
Protein binding 10-25%[2]
Metabolism Predominantly in the liver[3]
Half life 1–4 hours[3]
Excretion Urine (85-90%)[3]
Therapeutic considerations
Licence data

US

Pregnancy cat.

A(AU) C(US) Not tested but seems to be safe

Legal status

Unscheduled(AU) GSL(UK) OTC(US)

Routes Oral, rectal, intravenous

Mechanism of Action

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

Structure

This image is provided by the National Library of Medicine.

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 25°C (68° to 77°F)

Images

Drug Images

Package and Label Display Panel

Acetaminophen (oral solution)03.png
This image of the FDA label is provided by the National Library of Medicine.
Acetaminophen (oral solution)04.png
This image of the FDA label is provided by the National Library of Medicine.

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[4]

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

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. Granberg RA, Rasmuson AC (1999). "Solubility of paracetamol in pure solvents". Journal of Chemical & Engineering Data. 44 (6): 1391–95. doi:10.1021/je990124v.
  2. "Tylenol, Tylenol [[infants]]' Drops (acetaminophen) dosing, indications, interactions, adverse effects, and more". Medscape Reference. WebMD. Retrieved 10 May 2014. URL–wikilink conflict (help)
  3. 3.0 3.1 3.2 "Codapane Forte Paracetamol and codeine phosphate PRODUCT INFORMATION" (PDF). TGA eBusiness Services. Alphapharm Pty Limited. 29 April 2013. Retrieved 10 May 2014.
  4. "ACETAMINOPHEN ORAL SOLUTION- acetaminophen liquid".