Acetaminophen Drug Facts

SPL v1

SPL

SPL Set ID 5c0dbae2-328b-42b6-a8b6-55009f3c78e5

Route

ORAL

Published

Effective Date 2012-05-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (80 mg)

Inactive Ingredients

Aspartame Sucrose D&c Red No. 27 Fd&c Yellow No. 6 Magnesium Stearate Cellulose, Microcrystalline Stearic Acid

Identifiers & Packaging

Pill Appearance

Imprint: Logo;051 Shape: round Color: pink Size: 8 mm Score: 1

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2012-02-16

Description

Acetaminophen

Purpose

Pain Reliever / Fever Reducer

Medication Information

Purpose

Pain Reliever / Fever Reducer

Description

Acetaminophen

Uses

temporarily reduces fever and relieves minor aches and pains caused by

headache

common cold

flu

toothache

sore throat

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if the child takes

more than 5 doses in 24 hours, which is the maximum daily amount

with other drugs containing acetaminophen

Sore throat warning: If sore throat is severe, lasts for more than 2 days or is accompanied or fillowed 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.

Ask a doctor before use if the child has liver disease

Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin.

Stop use and ask a doctor if

pain gets worse or lasts more than 5 days

fever gets worse or lasts more than 3 days

redness or swelling is present

any new symptoms appear

Directions

this product does not contain directions or complete warnings for adult use

find correct does on chart below

if possible, use weight to dose, otherwise use age

chew tablets before swallowing

give dose every 4 hours while symptoms last

do not give more than 5 doses in 24 hours

Weight (pounds)	Age (years)	Dose (tablets)
72 - 95	11 - 12	4 - 6
60 - 71	9 - 10	4 - 5
48 - 59	6 - 8	4
36 - 47	4 - 5	3
24 - 35	2 - 3	2
under 24	under 2	ask a doctor

Active Ingredient

Acetaminophen

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical, even if you do not notice any signs or symptoms.

Package/label Principal Display Panel

Structured Label Content

Uses

temporarily reduces fever and relieves minor aches and pains caused by

headache

common cold

flu

toothache

sore throat

Purpose

Pain Reliever / Fever Reducer

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if the child takes

more than 5 doses in 24 hours, which is the maximum daily amount

with other drugs containing acetaminophen

Sore throat warning: If sore throat is severe, lasts for more than 2 days or is accompanied or fillowed 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.

Ask a doctor before use if the child has liver disease

Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin.

Stop use and ask a doctor if

pain gets worse or lasts more than 5 days

fever gets worse or lasts more than 3 days

redness or swelling is present

any new symptoms appear

Directions

this product does not contain directions or complete warnings for adult use

find correct does on chart below

if possible, use weight to dose, otherwise use age

chew tablets before swallowing

give dose every 4 hours while symptoms last

do not give more than 5 doses in 24 hours

Weight (pounds)	Age (years)	Dose (tablets)
72 - 95	11 - 12	4 - 6
60 - 71	9 - 10	4 - 5
48 - 59	6 - 8	4
36 - 47	4 - 5	3
24 - 35	2 - 3	2
under 24	under 2	ask a doctor

Active Ingredient (Active ingredient)

Acetaminophen

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical, even if you do not notice any signs or symptoms.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Advanced Ingredient Data

[{"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "80", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "ASPARTAME", "unii": "Z0H242BBR1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCROSE", "unii": "C151H8M554", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 27", "unii": "2LRS185U6K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily reduces fever and relieves minor aches and pains caused by headache common cold flu toothache sore throat", "Purpose": "Pain Reliever / Fever Reducer", "Warnings": "Liver warning: This product contains acetaminophen. Severe liver damage may occur if the child takes more than 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen Sore throat warning : If sore throat is severe, lasts for more than 2 days or is accompanied or fillowed 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. Ask a doctor before use if the child has liver disease Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin. Stop use and ask a doctor if pain gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days redness or swelling is present any new symptoms appear", "Directions": "this product does not contain directions or complete warnings for adult use find correct does on chart below if possible, use weight to dose, otherwise use age chew tablets before swallowing give dose every 4 hours while symptoms last do not give more than 5 doses in 24 hours Weight (pounds) Age (years) Dose (tablets) 72 - 95 11 - 12 4 - 6 60 - 71 9 - 10 4 - 5 48 - 59 6 - 8 4 36 - 47 4 - 5 3 24 - 35 2 - 3 2 under 24 under 2 ask a doctor", "Active ingredient": "Acetaminophen", "Keep Out of Reach of Children": "In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical, even if you do not notice any signs or symptoms."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:33.687652 · Updated: 2026-03-14T22:53:20.556394