Drug Facts
80a699b9-bf5c-4765-9e20-ccbc7e3ace7a
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acteminophen 500 mg
Medication Information
Warnings and Precautions
Liver Warning:This product contains acetaminophen. Severe liver damage may occur if you take:
-more than 4000 mg of acetaminophen 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.
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
Ask a doctor before use if you haveliver disease
Ask a doctor or pharmacist before use if youare taking the blood thinning drug warfarin
Stop use and ask a doctor if:
-Pain gets worse or lasts for more than 10 days
-Fever gets worse or lasts for more than 3 days
-New symptoms occur
-Redness or swelling is present
These could be signs of a serious condition.
If pregnant of breast-feeding,ask a health professional before use.
Indications and Usage
Temporary relieves minor aches and pains due to: the common cold, headache, toothache, muscular aches, backache, minor pains of arthritis, and menstrual and premenstrual cramps
Temporarily reduces fever.
Dosage and Administration
Do not take more than directed (see overdose warnings)
Adults and children 12 years of age and older: Take 2 caplets every 4 to 6 hours while symptoms last.
Do not take more than 6 caplets in 24 hours, unless directed by a doctor.
Do not use more than 10 days unless directed by a doctor.
Children under 12 years of age: ask a doctor
Description
Acteminophen 500 mg
Section 50565-1
Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or 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 of symptoms.
Section 51727-6
povidone, pregelatinized starch, sodium starch glycolate, stearic acid
Section 51945-4
Section 55105-1
Pain reliever / Fever reducer
Section 55106-9
Acteminophen 500 mg
Structured Label Content
Indications and Usage (34067-9)
Temporary relieves minor aches and pains due to: the common cold, headache, toothache, muscular aches, backache, minor pains of arthritis, and menstrual and premenstrual cramps
Temporarily reduces fever.
Dosage and Administration (34068-7)
Do not take more than directed (see overdose warnings)
Adults and children 12 years of age and older: Take 2 caplets every 4 to 6 hours while symptoms last.
Do not take more than 6 caplets in 24 hours, unless directed by a doctor.
Do not use more than 10 days unless directed by a doctor.
Children under 12 years of age: ask a doctor
Warnings and Precautions (34071-1)
Liver Warning:This product contains acetaminophen. Severe liver damage may occur if you take:
-more than 4000 mg of acetaminophen 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.
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
Ask a doctor before use if you haveliver disease
Ask a doctor or pharmacist before use if youare taking the blood thinning drug warfarin
Stop use and ask a doctor if:
-Pain gets worse or lasts for more than 10 days
-Fever gets worse or lasts for more than 3 days
-New symptoms occur
-Redness or swelling is present
These could be signs of a serious condition.
If pregnant of breast-feeding,ask a health professional before use.
Section 50565-1 (50565-1)
Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or 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 of symptoms.
Section 51727-6 (51727-6)
povidone, pregelatinized starch, sodium starch glycolate, stearic acid
Section 51945-4 (51945-4)
Section 55105-1 (55105-1)
Pain reliever / Fever reducer
Section 55106-9 (55106-9)
Acteminophen 500 mg
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T12:07:24.247650 · Updated: 2026-03-14T23:10:48.259693