Drug Facts
7198fefd-b95b-4c8e-b70a-5ea061098baa
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen
Purpose
Pain reliever/fever reducer
Medication Information
Purpose
Pain reliever/fever reducer
Dosage and Administration
- do not take more than directed (see overdose warning)
- adults and children 12 years and over
- take 2 caplets every 4 to 6 hours while symptoms last
- do not take more than 8 caplets in 24 hours
- do not take for more than 10 days unless directed by a doctor
- children under 12 years: do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage
Description
Acetaminophen
Uses
- temporarily relieves minor aches and pains due to:
- headache
- backache
- toothache
- the common cold
- minor pain of arthritis
- muscular aches
- premenstrual and menstrual cramps
- temporarily reduces fever
Section 50565-1
Keep out of reach of children
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damamge. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Section 50566-9
- pain gets worse or lasts more than 10 days
- 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.
Section 50569-3
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.
Section 51727-6
Inactive Ingredients
Polyvinylpyrrolidone, pregelatinized starch, sodium starch glycolate, stearic acid
Section 51945-4
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use.
Warnings
Liver warning: This product contains acetaminophen. The maximum daily dosse of this product is 6 caplets (3,000 mg) in 24 hours. Severe liver damage may occur if you take:
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Active Ingredient
Acetaminophen
Other Information
- store 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Structured Label Content
Uses
- temporarily relieves minor aches and pains due to:
- headache
- backache
- toothache
- the common cold
- minor pain of arthritis
- muscular aches
- premenstrual and menstrual cramps
- temporarily reduces fever
Dosage and Administration (34068-7)
- do not take more than directed (see overdose warning)
- adults and children 12 years and over
- take 2 caplets every 4 to 6 hours while symptoms last
- do not take more than 8 caplets in 24 hours
- do not take for more than 10 days unless directed by a doctor
- children under 12 years: do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage
Section 50565-1 (50565-1)
Keep out of reach of children
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damamge. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Section 50566-9 (50566-9)
- pain gets worse or lasts more than 10 days
- 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.
Section 50569-3 (50569-3)
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.
Section 51727-6 (51727-6)
Inactive Ingredients
Polyvinylpyrrolidone, pregelatinized starch, sodium starch glycolate, stearic acid
Section 51945-4 (51945-4)
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use.
Purpose
Pain reliever/fever reducer
Warnings
Liver warning: This product contains acetaminophen. The maximum daily dosse of this product is 6 caplets (3,000 mg) in 24 hours. Severe liver damage may occur if you take:
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Active Ingredient (Active ingredient)
Acetaminophen
Other Information
- store 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T11:55:49.919451 · Updated: 2026-03-14T22:53:48.902596