Counteract Pain Content Of Labeling
7faf76b4-7f25-377d-e053-2a91aa0a19d4
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active Ingredients (in each caplet) Acetaminophen 500 mg
Medication Information
Recent Major Changes
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Warnings and Precautions
Warnings
Liver Warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 8 caplets 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
Indications and Usage
Uses
- for the temporary relief of minor aches and pains due to:
-
- headache
- the common cold
- backache
- minor pain of arthritis
- toothache
- muscular aches
- premenstrual and menstrual cramps
- temporarily reduces fever
Dosage and Administration
Directions
- do not take more than directed (see overdose warning)
- adults and children 12 years and over
-
- take 2 caplets every 4 to 6 hours while symptoms last
- do not take more than 8 caplets in 24 hours
- do not take more than 10 days unless directed by a doctor
- children under 12 years: do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage
Description
Active Ingredients (in each caplet) Acetaminophen 500 mg
Section 34088-5
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. (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 44425-7
Other information
- store at room temperature
Section 50565-1
Keep out of reach of children.
Section 50566-9
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
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.
Section 51727-6
Inactive ingredients Hypromellose, Polyethylene Glycol, Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid.
Section 51945-4
Section 53413-1
Questions or comments? If you have any questions or comments, or to report and adverse event, please contact 1-800-282-3000.
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1
Purposes
Pain Reliever/fever reducer
Section 55106-9
Active Ingredients (in each caplet)
Acetaminophen 500 mg
Structured Label Content
Recent Major Changes (34066-1)
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Indications and Usage (34067-9)
Uses
- for the temporary relief of minor aches and pains due to:
-
- headache
- the common cold
- backache
- minor pain of arthritis
- toothache
- muscular aches
- premenstrual and menstrual cramps
- temporarily reduces fever
Dosage and Administration (34068-7)
Directions
- do not take more than directed (see overdose warning)
- adults and children 12 years and over
-
- take 2 caplets every 4 to 6 hours while symptoms last
- do not take more than 8 caplets in 24 hours
- do not take more than 10 days unless directed by a doctor
- children under 12 years: do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage
Warnings and Precautions (34071-1)
Warnings
Liver Warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 8 caplets 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
Section 34088-5 (34088-5)
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. (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 44425-7 (44425-7)
Other information
- store at room temperature
Section 50565-1 (50565-1)
Keep out of reach of children.
Section 50566-9 (50566-9)
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
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.
Section 51727-6 (51727-6)
Inactive ingredients Hypromellose, Polyethylene Glycol, Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid.
Section 51945-4 (51945-4)
Section 53413-1 (53413-1)
Questions or comments? If you have any questions or comments, or to report and adverse event, please contact 1-800-282-3000.
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1 (55105-1)
Purposes
Pain Reliever/fever reducer
Section 55106-9 (55106-9)
Active Ingredients (in each caplet)
Acetaminophen 500 mg
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:05:46.036203 · Updated: 2026-03-14T23:08:04.646392