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SPL v5
SPL
SPL Set ID 8f3c3cea-a72f-48c5-817d-aea8745efe67
Route
ORAL
Published
Effective Date 2019-01-17
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: arthritis headache muscular aches temporarily reduces fever the common cold toothache backache menstrual cramps

Dosage and Administration

do not take more than directed (see overdose warning). take 2 caplets every 8 hours with water. Swallow whole—do not crush, chew, split or dissolve. Do not take more than 6 caplets in 24 hours. Do not use for more than 10 days unless directed by a doctor. Children Under 18 years of age ask a doctor.

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 or any other blood thinner.

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

Povidone, Pregelatinized Starch, Crosspovidone, Stearic Acid, Titanium Dioxide, Carnauba Wax, Hypromellose, Polyethylene Glycol.

Section 51945-4

Updated carton display

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 650 mg


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

do not take more than directed (see overdose warning). take 2 caplets every 8 hours with water. Swallow whole—do not crush, chew, split or dissolve. Do not take more than 6 caplets in 24 hours. Do not use for more than 10 days unless directed by a doctor. Children Under 18 years of age ask a doctor.

Warnings and Precautions (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.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children .

Section 50566-9 (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 (50568-5)

Ask your doctor or pharmacist before use if you are taking the blood thinning drug warfarin or any other blood thinner.

Section 50569-3 (50569-3)

Ask a doctor before use if you have liver disease

Section 50570-1 (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 (51727-6)

Povidone, Pregelatinized Starch, Crosspovidone, Stearic Acid, Titanium Dioxide, Carnauba Wax, Hypromellose, Polyethylene Glycol.

Section 51945-4 (51945-4)

Updated carton display

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 650 mg


Raw Label Data

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