DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 1)

Inactive Ingredients

Starch, Corn Cellulose, Microcrystalline Povidone Sodium Starch Glycolate Type A Corn Stearic Acid

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2015-04-10

Medication Information

Warnings and Precautions

Warnings:

Liver Warning: This product contains Acetaminophen. Severe liver damage may occur if: • you take more than 8 tablets in 24 hours • you take with other drugs containing acetaminophen (prescription or non-prescription) • you have 3 or more alcoholic drinks every day while using this product

Do not use: • with any other product containing acetaminophen • for more than 10 days for pain unless directed by a doctor • for more than 3 days for fever unless directed by a doctor

When using this product do not exceed recommended dose.

Stop use and ask a doctor if: • symptoms do not improve • pain or fever persists or gets worse • new symptoms occur • redness or swelling is present

Indications and Usage

Uses: temporarily relieves minor aches and pains associated with: • headaches • colds • toothache • minor arthritis pain • muscular aches • menstrual cramps • backache

Dosage and Administration

Directions:

Adults and children 12 years of age and older: Take 2 tablets every 4 to 6 hours or as needed, do not exceed 8 tablets in 24 hours, or asdirected by a doctor.

Children under 12 years: Do not use this product: this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns.

Description

ACTIVE INGREDIENT IN EACH TABLET- Acetaminophen 500 mg

Section 50565-1

KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 51727-6

Inactive Ingredients: corn starch, microcrystalline cellulose, povidone, sodium starch glycolate, and stearic acid

Section 51945-4

Section 53414-9

If pregnant or breast-feeding baby, ask a health professional before use.

Section 55105-1

pain reliever/fever reducer

Section 55106-9

ACTIVE INGREDIENT IN EACH TABLET-

Acetaminophen 500 mg

Structured Label Content

Indications and Usage (34067-9)

Uses: temporarily relieves minor aches and pains associated with: • headaches • colds • toothache • minor arthritis pain • muscular aches • menstrual cramps • backache

Dosage and Administration (34068-7)

Directions:

Adults and children 12 years of age and older: Take 2 tablets every 4 to 6 hours or as needed, do not exceed 8 tablets in 24 hours, or asdirected by a doctor.

Children under 12 years: Do not use this product: this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns.

Warnings and Precautions (34071-1)

Warnings:

Liver Warning: This product contains Acetaminophen. Severe liver damage may occur if: • you take more than 8 tablets in 24 hours • you take with other drugs containing acetaminophen (prescription or non-prescription) • you have 3 or more alcoholic drinks every day while using this product

Do not use: • with any other product containing acetaminophen • for more than 10 days for pain unless directed by a doctor • for more than 3 days for fever unless directed by a doctor

When using this product do not exceed recommended dose.

Stop use and ask a doctor if: • symptoms do not improve • pain or fever persists or gets worse • new symptoms occur • redness or swelling is present

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 51727-6 (51727-6)

Inactive Ingredients: corn starch, microcrystalline cellulose, povidone, sodium starch glycolate, and stearic acid

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding baby, ask a health professional before use.

Section 55105-1 (55105-1)

pain reliever/fever reducer

Section 55106-9 (55106-9)

ACTIVE INGREDIENT IN EACH TABLET-

Acetaminophen 500 mg

Advanced Ingredient Data

[{"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "1", "strengthDenominatorUnit": "1"}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A CORN", "unii": "AG9B65PV6B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses: temporarily relieves minor aches and pains associated with: • headaches • colds • toothache • minor arthritis pain • muscular aches • menstrual cramps • backache", "34068-7": "Directions: Adults and children 12 years of age and older: Take 2 tablets every 4 to 6 hours or as needed, do not exceed 8 tablets in 24 hours, or asdirected by a doctor. Children under 12 years: Do not use this product: this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns.", "34071-1": "Warnings: Liver Warning: This product contains Acetaminophen. Severe liver damage may occur if: • you take more than 8 tablets in 24 hours • you take with other drugs containing acetaminophen (prescription or non-prescription) • you have 3 or more alcoholic drinks every day while using this product Do not use: • with any other product containing acetaminophen • for more than 10 days for pain unless directed by a doctor • for more than 3 days for fever unless directed by a doctor When using this product do not exceed recommended dose. Stop use and ask a doctor if: • symptoms do not improve • pain or fever persists or gets worse • new symptoms occur • redness or swelling is present", "50565-1": "KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "51727-6": "Inactive Ingredients: corn starch, microcrystalline cellulose, povidone, sodium starch glycolate, and stearic acid", "53414-9": "If pregnant or breast-feeding baby, ask a health professional before use.", "55105-1": "pain reliever/fever reducer", "55106-9": "ACTIVE INGREDIENT IN EACH TABLET- Acetaminophen 500 mg"}