Acetaminophen Solution
FDA Label NDC 55154-9449

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 107, Llc for the product Acetaminophen (NDC 55154-9449). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each 5 ml teaspoonful), purpose, uses, liver warning, allergy alert, sore throat warning, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredient (in Each 5 Ml Teaspoonful)

→ Purpose

→ Uses

→ Liver Warning

→ Allergy Alert

→ Sore Throat Warning

→ Do Not Use

→ Ask A Doctor Before Use If You Have

→ Ask A Doctor Or Pharmacist Before Use If

→ Stop Use And Ask A Doctor If

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Overdose Warning

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Manufactured By:

→ Principal Display Panel

Other

Drug Facts

Active Ingredient (In Each 5 Ml Teaspoonful)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

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

Liver Warning

This product contains acetaminophen. Severe liver damage may occur if you take:

adult takes more than 6 doses in 24 hours, which is the maximum daily amount
child takes more than 5 doses in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Allergy Alert

Acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

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.
for more than 10 days for pain unless directed by a doctor
for more than 3 days for fever unless directed by a doctor
if you are allergic to acetaminophen or any of the inactive ingredients of this product

Ask A Doctor Before Use If You Have

liver disease

Ask A Doctor Or Pharmacist Before Use If

you are taking the blood thinning drug warfarin

Stop Use And Ask A Doctor If

symptoms do not improve
new symptoms occur
pain or fever persists or gets worse

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdose Warning

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.

Directions

do not take more than directed (see overdose warning)

age	dose
adults and children 12 years of age and over	20.3 mL (650 mg) every 4 to 6 hours not to exceed 6 doses in a 24-hour period
children 6 to under 12 years of age	10.15 mL (325 mg) every 4 hours not to exceed 5 doses in a 24-hour period
children 4 to under 6 years of age	7.5 mL (240 mg) every 4 hours not to exceed 5 doses in a 24-hour period
children 2 to under 4 years of age	5 mL (160 mg) every 4 hours not to exceed 5 doses in a 24-hour period
children under 2 years of age	consult a doctor

Other Information

■ sodium content: 2 mg/5 mL

■ store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature]

■ keep tightly closed ■ protect from light

■ a red, cherry flavored solution supplied in the following oral dosage forms:

Available overbagged with 5 x 20.3 mL unit dose cups per bag, NDC 55154-9449-5

Inactive Ingredients

Citric acid, FD&C Red No. 40, flavoring, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol and sucrose.