342r Apap

342r Apap
SPL v2
SPL
SPL Set ID 2569383a-4a05-4ddb-852e-b37e487ffcde
Route
ORAL
Published
Effective Date 2012-05-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Carnauba Wax Fd&c Red No. 40 Hypromelloses Polyethylene Glycol 400 Polyethylene Glycol 8000 Povidone Starch, Corn Sodium Starch Glycolate Type A Potato Stearic Acid Sucralose Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: TCL342 Shape: round Color: red Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-05-01
Description

Active Ingredient: Each tablet contains Acetaminophen 500 mg

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, which is the maximum daily amount; 3 or more alcoholic drinks every day while using this product; with other drugs containing acetaminophen.

Overdose warning: Taking more than the recommended dose (0verdose) may cause liver damage. in case of overdose, get medical help or contact a Poison Control Center (1-800-222-1221) right way. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.



Indications and Usage

INDICATIONS AND USAGE:

Pain Reliever – temporarily relieves minor aches and pains due to: the common cold, headache, backache, muscular aches, toothache, premenstrual and menstrual cramps, minor pain of arthritis. Temporarily reduces fever.
Dosage and Administration

Do not take more than directed (see overdosage warning)

Adults and children 12 years and over: take 2 tablets (1,000 mg) every 6 hours while symptoms last; do not take more than 6 tablets (3,000 mg) 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: Do not use this adult extra strength product in children under 12 years of age, this will provide more than the recommended dose (overdosage) of acetaminophen and may cause liver damage



Description

Active Ingredient: Each tablet contains Acetaminophen 500 mg

Section 50565-1

Keep Out of the Reach of Children: In case of overdose, get medical help or contact a Poison Control Center right away
Section 51727-6

CARNAUBA WAX, FD-C RED NO. 40 ALUMINUM LAKE, HYPROMELLOSE, POLYETHYLENE GLYCOL(PEG) 400, POLYETHYLENE GLYCOL (peg) 8000, POVIDONE, PREGELATINIZED STARCH, SODIUM STARCH GLYCOLATE**, STEARIC ACID, SUCRALOSE, TITANIUM DIOXIDE



** MAY CONTAIN THIS INGREDIENT
Section 51945-4

Section 55105-1

PURPOSE: Pain Reliever - fever reducer

Section 55106-9

Active Ingredient: Each tablet contains Acetaminophen 500 mg

Structured Label Content

Indications and Usage (34067-9)

INDICATIONS AND USAGE:

Pain Reliever – temporarily relieves minor aches and pains due to: the common cold, headache, backache, muscular aches, toothache, premenstrual and menstrual cramps, minor pain of arthritis. Temporarily reduces fever.
Dosage and Administration (34068-7)

Do not take more than directed (see overdosage warning)

Adults and children 12 years and over: take 2 tablets (1,000 mg) every 6 hours while symptoms last; do not take more than 6 tablets (3,000 mg) 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: Do not use this adult extra strength product in children under 12 years of age, this will provide more than the recommended dose (overdosage) 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 tablets in 24 hours, which is the maximum daily amount; 3 or more alcoholic drinks every day while using this product; with other drugs containing acetaminophen.

Overdose warning: Taking more than the recommended dose (0verdose) may cause liver damage. in case of overdose, get medical help or contact a Poison Control Center (1-800-222-1221) right way. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.



Section 50565-1 (50565-1)

Keep Out of the Reach of Children: In case of overdose, get medical help or contact a Poison Control Center right away
Section 51727-6 (51727-6)

CARNAUBA WAX, FD-C RED NO. 40 ALUMINUM LAKE, HYPROMELLOSE, POLYETHYLENE GLYCOL(PEG) 400, POLYETHYLENE GLYCOL (peg) 8000, POVIDONE, PREGELATINIZED STARCH, SODIUM STARCH GLYCOLATE**, STEARIC ACID, SUCRALOSE, TITANIUM DIOXIDE



** MAY CONTAIN THIS INGREDIENT
Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

PURPOSE: Pain Reliever - fever reducer

Section 55106-9 (55106-9)

Active Ingredient: Each tablet contains Acetaminophen 500 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:42.568388 · Updated: 2026-03-14T22:55:22.018235