acetaminophen 500 mg
14bcbaf9-76b6-f8ba-e063-6294a90a91f6
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
Medication Information
Warnings and Precautions
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
■ more than 4,000 mg in 24 hours, which is the maximum daily amount
■ 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.
Active Ingredient
Active Ingredient (in each tablet)
Acetaminophen 500 mg
Indications and Usage
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
Dosage and Administration
Directions
■ do not use more than directed (see overdose warning)
Adults and children 12 years and over
■ take 2 tablets every 6 hours while symptoms last.
■ do not take more than 6 tablets in 24 hours, unless directed by a doctor
■ do not use for more than 10 days unless directed by a doctor
Children under 12 years
Ask a doctor
Description
Drug Facts
Section 42229-5
Drug Facts
Section 50565-1
Keep out of reach of children.
Overdose Warning:
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 for children even if you do not notice any signs or symptoms.
Section 50566-9
Stop using and ask a doctor if
■ pain gets worse or lasts more than for 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 50568-5
Ask a doctor or pharmacist before use if
■ you are taking the blood thinning drug warfarin
Section 50569-3
Ask a doctor before use if you have
■ liver disease
Section 50570-1
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 in this product
Section 51727-6
Inactive ingredients
corn starch*, hypromellose*, polyethylene glycol*, povidone (K-30)*, pregelatinized starch*, purified water*, sodium starch glycolate, stearic acid, titanium dioxide*
* May contain
Section 51945-4
Medique
Extra Strength APAP
Non-Aspirin Tablets
THIS PACKAGE IS FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN.
Pain Reliever / Fever Reducer • Acetaminophen 500 mg
Compare active ingredient to Tylenol®
Registered McNeil Products
Tamper Evident Unit Dose Packets
24 Tablets
(12 x 2)
Section 55105-1
Purpose
Pain reliever / fever reducer
Section 60561-8
Other information
■ store at room temperature 59º-86ºF (15º-30ºC)
■ tamper-evident sealed packets
■ do not use any opened or torn packets
Structured Label Content
Warnings and Precautions (34071-1)
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
■ more than 4,000 mg in 24 hours, which is the maximum daily amount
■ 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.
Active Ingredient (55106-9)
Active Ingredient (in each tablet)
Acetaminophen 500 mg
Indications and Usage (34067-9)
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
Dosage and Administration (34068-7)
Directions
■ do not use more than directed (see overdose warning)
Adults and children 12 years and over
■ take 2 tablets every 6 hours while symptoms last.
■ do not take more than 6 tablets in 24 hours, unless directed by a doctor
■ do not use for more than 10 days unless directed by a doctor
Children under 12 years
Ask a doctor
Section 42229-5 (42229-5)
Drug Facts
Section 50565-1 (50565-1)
Keep out of reach of children.
Overdose Warning:
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 for children even if you do not notice any signs or symptoms.
Section 50566-9 (50566-9)
Stop using and ask a doctor if
■ pain gets worse or lasts more than for 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 50568-5 (50568-5)
Ask a doctor or pharmacist before use if
■ you are taking the blood thinning drug warfarin
Section 50569-3 (50569-3)
Ask a doctor before use if you have
■ liver disease
Section 50570-1 (50570-1)
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 in this product
Section 51727-6 (51727-6)
Inactive ingredients
corn starch*, hypromellose*, polyethylene glycol*, povidone (K-30)*, pregelatinized starch*, purified water*, sodium starch glycolate, stearic acid, titanium dioxide*
* May contain
Section 51945-4 (51945-4)
Medique
Extra Strength APAP
Non-Aspirin Tablets
THIS PACKAGE IS FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN.
Pain Reliever / Fever Reducer • Acetaminophen 500 mg
Compare active ingredient to Tylenol®
Registered McNeil Products
Tamper Evident Unit Dose Packets
24 Tablets
(12 x 2)
Section 55105-1 (55105-1)
Purpose
Pain reliever / fever reducer
Section 60561-8 (60561-8)
Other information
■ store at room temperature 59º-86ºF (15º-30ºC)
■ tamper-evident sealed packets
■ do not use any opened or torn packets
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:06:56.507513 · Updated: 2026-03-14T23:10:01.237919