251
e65dbd01-2d5e-4067-ad98-98d879cfb5ee
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen 500 mg
Purpose
Pain Reliever/Fever Reducer
Medication Information
Purpose
Pain Reliever/Fever Reducer
Description
Acetaminophen 500 mg
Uses
- temporarily relieves minor aches and pains
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take:
• more than 8 gelcaps (4,000 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 have liver disease.
Ask a doctor or pharmacist before use if you are taking the
blood thinning drug warfarin.
Stop use and ask a doctor if • 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.
If pregnant or breast-feeding, ask a health professional before use.
Directions
- do not take more than directed
- adults and children 12 years and over: Take 2 gelcaps every
6 hours, as needed; not more than 6 gelcaps in 24 hours.
Do not take for more than 10 days unless directed by a doctor.
- children under 12 years: ask a doctor
Package Label
Other Information
- store at 20⁰C-25⁰C (68⁰F-77⁰F)
- avoid high humidity
Inactive Ingredients
Croscarmellose Sodium, D and C Red 33, FD and C Blue 1, FD and C Red 40, Gelatin, Hydroxypropyl Cellulose, Hypromellose, Iron Oxide, PEG, Povidone, Propylene Glycol, Shellac Glaze, Starch, Stearic Acid, Titanium Dioxide.
Keep Out of Reach of Children
Overdose Warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Active Ingredient (in Each Gelcap)
Acetaminophen 500 mg
Structured Label Content
Uses
- temporarily relieves minor aches and pains
- temporarily reduces fever
Purpose
Pain Reliever/Fever Reducer
Warnings
Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take:
• more than 8 gelcaps (4,000 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 have liver disease.
Ask a doctor or pharmacist before use if you are taking the
blood thinning drug warfarin.
Stop use and ask a doctor if • 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.
If pregnant or breast-feeding, ask a health professional before use.
Directions
- do not take more than directed
- adults and children 12 years and over: Take 2 gelcaps every
6 hours, as needed; not more than 6 gelcaps in 24 hours.
Do not take for more than 10 days unless directed by a doctor.
- children under 12 years: ask a doctor
Package Label (Package label)
Other Information
- store at 20⁰C-25⁰C (68⁰F-77⁰F)
- avoid high humidity
Inactive Ingredients
Croscarmellose Sodium, D and C Red 33, FD and C Blue 1, FD and C Red 40, Gelatin, Hydroxypropyl Cellulose, Hypromellose, Iron Oxide, PEG, Povidone, Propylene Glycol, Shellac Glaze, Starch, Stearic Acid, Titanium Dioxide.
Keep Out of Reach of Children (Keep out of reach of children)
Overdose Warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Active Ingredient (in Each Gelcap) (Active ingredient (in each gelcap))
Acetaminophen 500 mg
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:01:28.336709 · Updated: 2026-03-14T23:01:25.991637