Package Labeling:

SPL v8

SPL

SPL Set ID dac7c13d-c021-4a6e-9b14-0e312dd0ea2f

Route

ORAL

Published

Effective Date 2021-08-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging

Description

Drug Facts

Medication Information

Warnings and Precautions

Liver warning : This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product.

Indications and Usage

temporarily relieves minor aches and pains due to: headache backache minor pain of arthritis temporarily reduces fever the common cold toothache menstrual cramps muscular aches

Dosage and Administration

do not take more than directed (see overdose warning). Adults and children 12 years and over: take 2 caplets every 4 to 6 hours Do not take more than 8 caplets of this product in 24 hours. Children under 12 years: do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Description

Drug Facts

Section 42229-5

Drug Facts

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 appear redness or swelling is present These could be signs of a serious condition

Section 50568-5

Ask your 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

with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you have ever had an allergic reaction to acetaminophen or any of the inactive ingredients in this product.

Section 51727-6

CARNAUBA WAX HYPROMELLOSES POLYETHYLENE GLYCOL, UNSPECIFIED ( POVIDONE CROSPOVIDONE STEARIC ACID TITANIUM DIOXIDE STARCH, CORN

Section 51945-4

Section 53413-1

call toll free 1-855-470-6722

Section 53414-9

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

Section 55105-1

Pain reliever/fever reducer

Section 55106-9

Acetaminophen 500 mg

Structured Label Content

Indications and Usage (34067-9)

temporarily relieves minor aches and pains due to: headache backache minor pain of arthritis temporarily reduces fever the common cold toothache menstrual cramps muscular aches

Dosage and Administration (34068-7)

Warnings and Precautions (34071-1)

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children .

Section 50566-9 (50566-9)

Section 50568-5 (50568-5)

Ask your 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)

Section 51727-6 (51727-6)

CARNAUBA WAX HYPROMELLOSES POLYETHYLENE GLYCOL, UNSPECIFIED ( POVIDONE CROSPOVIDONE STEARIC ACID TITANIUM DIOXIDE STARCH, CORN

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

call toll free 1-855-470-6722

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Pain reliever/fever reducer

Section 55106-9 (55106-9)

Acetaminophen 500 mg

Raw Label Data

All Sections (JSON)

{"34067-9": "temporarily relieves minor aches and pains due to: headache backache minor pain of arthritis temporarily reduces fever the common cold toothache menstrual cramps muscular aches", "34068-7": "do not take more than directed (see overdose warning). Adults and children 12 years and over: take 2 caplets every 4 to 6 hours Do not take more than 8 caplets of this product in 24 hours. Children under 12 years: do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.", "34071-1": "Liver warning : This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product.", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children .", "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 appear redness or swelling is present These could be signs of a serious condition", "50568-5": "Ask your doctor or pharmacist before use if you are taking the blood thinning drug warfarin", "50569-3": "Ask a doctor before use if you have liver disease", "50570-1": "with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you have ever had an allergic reaction to acetaminophen or any of the inactive ingredients in this product.", "51727-6": "CARNAUBA WAX HYPROMELLOSES POLYETHYLENE GLYCOL, UNSPECIFIED ( POVIDONE CROSPOVIDONE STEARIC ACID TITANIUM DIOXIDE STARCH, CORN", "51945-4": "1", "53413-1": "call toll free 1-855-470-6722", "53414-9": "If pregnant or breast-feeding , ask a health professional before use.", "55105-1": "Pain reliever/fever reducer", "55106-9": "Acetaminophen 500 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:45.968594 · Updated: 2026-02-15T12:02:45.908471