Drug Facts
91acc132-01b6-467b-9af5-70f4dc93e087
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
temporary relief of minor aches and pains associated with
- common cold
- headache
- toothache
- muscular aches
- backache
- arthritis
- menstrual cramps
- temporarily reduces fever
Warnings
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.
Directions
- do not use more than directed (see overdose warning)
- adults and children 12 years and over: take 2 tablets every 4 to 6 hours. Do not take more than 8 tablets in 24 hours.
- Do not use more than 10 days unless directed by a doctor
- children under 12 years of age: do not use this extra strength product; this will provide more than the recommended dose (overdose) and could cause serious health problems.
Do Not Use
- if you are allergic to acetaminophen
- with any other drug containing acetaminophen (prescription or nonprescription).
If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Other Information
- store between 20°-25°C (68°-77°F)
- do not use if imprinted safety seal under cap is broken or missing
Inactive Ingredients
corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid
Principal Display Panel
Stop Use and Ask A Doctor If
- symptoms do not improve
- pain gets worse or lasts for more than 10 days
- pain get worse or lasts more than 5 days in children under 12 years
- fever gets worse or lasts for more than 3 days
- new symptoms occur
- redness or swelling is present
- a rare sensitivity reaction occurs
- You may report side effects to 1-888-952-0050
If Pregnant Or Breast Feeding
ask a health professional before use.
Keep Out of Reach of Children
In case of accidental overdose, contact a doctor or 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.
Active Ingredient (in Each Tablet)
Acetaminophen 500 mg
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.
Structured Label Content
Uses
temporary relief of minor aches and pains associated with
- common cold
- headache
- toothache
- muscular aches
- backache
- arthritis
- menstrual cramps
- 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 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.
Directions
- do not use more than directed (see overdose warning)
- adults and children 12 years and over: take 2 tablets every 4 to 6 hours. Do not take more than 8 tablets in 24 hours.
- Do not use more than 10 days unless directed by a doctor
- children under 12 years of age: do not use this extra strength product; this will provide more than the recommended dose (overdose) and could cause serious health problems.
Do Not Use (Do not use)
- if you are allergic to acetaminophen
- with any other drug containing acetaminophen (prescription or nonprescription).
If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Other Information (Other information)
- store between 20°-25°C (68°-77°F)
- do not use if imprinted safety seal under cap is broken or missing
Inactive Ingredients (Inactive ingredients)
corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid
Principal Display Panel
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
- symptoms do not improve
- pain gets worse or lasts for more than 10 days
- pain get worse or lasts more than 5 days in children under 12 years
- fever gets worse or lasts for more than 3 days
- new symptoms occur
- redness or swelling is present
- a rare sensitivity reaction occurs
- You may report side effects to 1-888-952-0050
If Pregnant Or Breast Feeding (If pregnant or breast-feeding)
ask a health professional before use.
Keep Out of Reach of Children (Keep out of reach of children)
In case of accidental overdose, contact a doctor or 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.
Active Ingredient (in Each Tablet) (Active Ingredient (in each tablet))
Acetaminophen 500 mg
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
liver disease
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
taking the blood thinning drug warfarin.
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:02:20.783543 · Updated: 2026-03-14T23:01:50.647319