Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID b2a70284-f183-4d65-928e-057709f32a1f
Route
ORAL
Published
Effective Date 2016-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (110 1) Aspirin (162 1) Caffeine (32.4 1) Salicylamide (152 1)
Inactive Ingredients
Starch, Corn Magnesium Stearate Fd&c Yellow No. 6 Stearic Acid Microcrystalline Cellulose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-10-25

Description

Active Ingredients (In Each Tablet) Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg


Medication Information

Warnings and Precautions

Warnings:

Reye's Syndrome: 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), or have 3 or more alcoholic drinks every day while using this product.

Stomach Bleeding Warning: This product contains a nonsteroidal anti-inflammatory 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, or take more or for a longer time than directed.

Indications and Usage

Uses: For the temporary relief of pain from:

• headaches • colds • muscular aches

• menstrual cramps • toothaches

• minor arthritic pain • backaches

Dosage and Administration

Directions:

Adults and children: (12 years and older) Take 1 to 2 tablets with a full glass of water every 4 hours as needed. Do not exceed 6

tablets in 24 hours, or as directed by doctor.

Children: (under 12 years) Do not give to children under 12 years of age

Description

Active Ingredients (In Each Tablet) Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg

Section 50565-1

Keep out of reach of children.

Section 51727-6

SEE ORIGINAL BOX FOR COMPLETE PRODUCT INFORMATION

Section 51945-4

Section 53414-9

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

Section 55105-1

Pain reliever, Stimulant

Section 55106-9

Active Ingredients (In Each Tablet)

Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg


Structured Label Content

Indications and Usage (34067-9)

Uses: For the temporary relief of pain from:

• headaches • colds • muscular aches

• menstrual cramps • toothaches

• minor arthritic pain • backaches

Dosage and Administration (34068-7)

Directions:

Adults and children: (12 years and older) Take 1 to 2 tablets with a full glass of water every 4 hours as needed. Do not exceed 6

tablets in 24 hours, or as directed by doctor.

Children: (under 12 years) Do not give to children under 12 years of age

Warnings and Precautions (34071-1)

Warnings:

Reye's Syndrome: 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), or have 3 or more alcoholic drinks every day while using this product.

Stomach Bleeding Warning: This product contains a nonsteroidal anti-inflammatory 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, or 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)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Pain reliever, Stimulant

Section 55106-9 (55106-9)

Active Ingredients (In Each Tablet)

Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg


Advanced Ingredient Data


Raw Label Data

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