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Acetaminophen 500mg

OTC Oral RxCUI 198440
Contents

Overview

Active ingredient
Acetaminophen
Route
Oral
Label date
2025-12-24

Indications and usage

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

Purpose

Pain Reliever/fever reducer

Dosage and administration

Directions do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets, every 6 hours while symptoms last do not take more than 6 caplets in 24 hours, unless directed by a doctor do not use more than 10 days unless directed by a doctor children under 12 years ask a doctor

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4000 mg of acetaminophen in 24 hours 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 you have liver disease. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. 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 occur redness or swelling is present These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222).

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

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.

Overdosage

Overdose warning: In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222).

Pregnancy or breast-feeding

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

Active ingredient (label)

(in each caplet) Acetaminophen 500mg

Inactive ingredients

s hypromellose, povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid, talc, triacetin

Storage and handling

Other information Tamper Evident: do not use if imprinted safety seal under cap is broken or missing store at 20 o -25 o C (68 o -77 o F), excursions permitted between 15-30°C (59-86°F)

Keep out of reach of children

of children.