Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (250 1) Aspirin (65 1) Caffeine

Inactive Ingredients

Microcrystalline Cellulose Povidone Sodium Starch Glycolate Type A Corn Stearic Acid Starch, Corn Hypromelloses Maltodextrin Polyethylene Glycol, Unspecified Titanium Dioxide

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2016-10-25

Medication Information

Warnings and Precautions

WARNING:

Reye's Syndrome Warning: Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye’s Syndrome, a rare but serious illness reported to be associated with aspirin.

Liver Warning: This product contains Acetaminophen. Severe liver damage may occur if you take: more than 8 tablets in 24 hours

• with other drugs containing acetaminophen (prescription or non-prescription)

• 3 or more alcoholic drinks every day while using this product.

Stomach Bleeding Warning: This product contains nonsteroidal antiinflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you: have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug

• are age 60 or older • have 3 or more alcoholic drinks every day while using this product • take with other drugs containing an NSAID • take more or for a longer time than directed.

Indications and Usage

Uses: For the temporary relief of pain from:

• headaches • muscular aches

• menstrual cramps • toothaches

• minor arthritic pain • colds

Dosage and Administration

DIRECTIONS:

Adults: 2 tablets with a full glass of water every 6 hours as needed. Do not exceed 8 tablets in a 24 hour period.

Children under 12 years of age: Consult a doctor.

Description

Acetaminophen 250mg, Aspirin 250mg, Caffeine 65mg

Section 50565-1

Keep out of reach of children.

Section 51727-6

SEE ORIGINAL BOX FOR COMPLETE PRODUCT INFORMATION

Section 51945-4

res

Section 55105-1

Pin reliever, Stimulant

Section 55106-9

Acetaminophen 250mg, Aspirin 250mg, Caffeine 65mg

Structured Label Content

Indications and Usage (34067-9)

Uses: For the temporary relief of pain from:

• headaches • muscular aches

• menstrual cramps • toothaches

• minor arthritic pain • colds

Dosage and Administration (34068-7)

DIRECTIONS:

Adults: 2 tablets with a full glass of water every 6 hours as needed. Do not exceed 8 tablets in a 24 hour period.

Children under 12 years of age: Consult a doctor.

Warnings and Precautions (34071-1)

WARNING:

Reye's Syndrome Warning: Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye’s Syndrome, a rare but serious illness reported to be associated with aspirin.

Liver Warning: This product contains Acetaminophen. Severe liver damage may occur if you take: more than 8 tablets in 24 hours

• with other drugs containing acetaminophen (prescription or non-prescription)

• 3 or more alcoholic drinks every day while using this product.

Stomach Bleeding Warning: This product contains nonsteroidal antiinflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you: have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug

• are age 60 or older • have 3 or more alcoholic drinks every day while using this product • take with other drugs containing an NSAID • take more or for a longer time than directed.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

SEE ORIGINAL BOX FOR COMPLETE PRODUCT INFORMATION

Section 51945-4 (51945-4)

res

Section 55105-1 (55105-1)

Pin reliever, Stimulant

Section 55106-9 (55106-9)

Acetaminophen 250mg, Aspirin 250mg, Caffeine 65mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Uses: For the temporary relief of pain from: • headaches • muscular aches • menstrual cramps • toothaches • minor arthritic pain • colds", "34068-7": "DIRECTIONS: Adults: 2 tablets with a full glass of water every 6 hours as needed. Do not exceed 8 tablets in a 24 hour period. Children under 12 years of age: Consult a doctor.", "34071-1": "WARNING: Reye's Syndrome Warning: Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye’s Syndrome, a rare but serious illness reported to be associated with aspirin. Liver Warning: This product contains Acetaminophen. Severe liver damage may occur if you take: more than 8 tablets in 24 hours • with other drugs containing acetaminophen (prescription or non-prescription) • 3 or more alcoholic drinks every day while using this product. Stomach Bleeding Warning: This product contains nonsteroidal antiinflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you: have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • are age 60 or older • have 3 or more alcoholic drinks every day while using this product • take with other drugs containing an NSAID • take more or for a longer time than directed.", "50565-1": "Keep out of reach of children.", "51727-6": "SEE ORIGINAL BOX FOR COMPLETE PRODUCT INFORMATION", "51945-4": "res", "55105-1": "Pin reliever, Stimulant", "55106-9": "Acetaminophen 250mg, Aspirin 250mg, Caffeine 65mg"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information