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Acetaminophen Tablet Extended Release

OTC Oral RxCUI 1148399
Contents

Overview

Active ingredient
Acetaminophen
Route
Oral
Label date
2025-02-24

Indications and usage

Uses For Arthritis Pain temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache premenstrual and menstrual cramps the common cold headache toothache temporarily reduces fever For Muscle Aches & Pains temporarily relieves minor aches and pains due to: muscular aches backache minor pain of arthritis toothache premenstrual and menstrual cramps headache the common cold temporarily reduces fever

Purpose

Pain reliever/fever reducer

Dosage and administration

Directions For Arthritis Pain Do not take more than directed. See overdose warning adults: 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 under 18 years of age: ask a doctor For Muscle Aches & Pains Do not take more than directed. See overdose warning adults and children 12 years and over: 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 12 years: do not use

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 6 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product. Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away.

Do not use

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

Ask a doctor before use if

Ask a doctor before use if you have liver disease.

Ask a doctor or pharmacist before use if

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Stop use and ask a doctor if

Stop using 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 occur redness or swelling is present These could be signs of a serious condition.

Pregnancy or breast-feeding

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

Active ingredient (label)

(in each caplet) Acetaminophen 650 mg

Inactive ingredients

s carnauba wax, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin

Storage and handling

Other information store between 20-25°C (68-77°F) The FDA approved Dissolution methods differ from USP

Keep out of reach of children

of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.