Acetaminophen Usp 500 Mg
a30388fa-0d85-4eb3-babd-228170ebe96d
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
(in each caplet) Acetaminophen 500 mg
Purpose
Pain Reliever / Fever Reducer
Medication Information
Purpose
Pain Reliever / Fever Reducer
Description
(in each caplet) Acetaminophen 500 mg
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
Warnings
Liver warning: this product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3,000 mg) in 24 hours. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
do not use
- with any other drug containing acetaminophen (prescription or non prescription). 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 the 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
- redness or swelling is present
- new symptoms occur
-
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 (see over dose warning) adults & children 12 years and over :
- take 2 caplets every 6 hours while symptoms last
- do not take more than 6 caplets in 24 hours, unless directed by a doctor
- do not take for more than 10 days unless directed by a doctor
- children under 12 years : ask a doctor
Active Ingredient
(in each caplet)
Acetaminophen 500 mg
Other Information
- store at 15-30 °C (59-86 °F)
Inactive Ingredients
hypromellose, polyethylene glyocol, polyvinylpyrrolidone, pregelatinized corn starch, sodium starch glycolate, stearic acid, TITANIUM DIOXIDE
Questions Or Comments
call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
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.
Package Label.principal Display Panel
NDC: 54738-040-01 ..100 APAP 500mg tabs
NDC: 54738-040-03 ..1000 APAP 500mg tabs
Structured Label Content
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
Purpose
Pain Reliever / Fever Reducer
Warnings
Liver warning: this product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3,000 mg) in 24 hours. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
do not use
- with any other drug containing acetaminophen (prescription or non prescription). 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 the 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
- redness or swelling is present
- new symptoms occur
-
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 (see over dose warning) adults & children 12 years and over :
- take 2 caplets every 6 hours while symptoms last
- do not take more than 6 caplets in 24 hours, unless directed by a doctor
- do not take for more than 10 days unless directed by a doctor
- children under 12 years : ask a doctor
Active Ingredient
(in each caplet)
Acetaminophen 500 mg
Other Information
- store at 15-30 °C (59-86 °F)
Inactive Ingredients
hypromellose, polyethylene glyocol, polyvinylpyrrolidone, pregelatinized corn starch, sodium starch glycolate, stearic acid, TITANIUM DIOXIDE
Questions Or Comments (Questions or Comments)
call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
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.
Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)
NDC: 54738-040-01 ..100 APAP 500mg tabs
NDC: 54738-040-03 ..1000 APAP 500mg tabs
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T11:56:26.105953 · Updated: 2026-03-14T22:54:52.931560