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.
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 55106-9
Active Ingredient (in each tablet)
Acetaminophen 500 mg
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
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
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.
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 55106-9 (55106-9)
Active Ingredient (in each tablet)
Acetaminophen 500 mg
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