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Acetaminophen

Dosage form
CAPSULE
Labeler
FREDS, INC
Label updated
2017-07-17
Retrieved
2026-09-07
Active ingredients
ACETAMINOPHEN
View original label and images on DailyMed ↗
Active ingredient

(in each Caplet)
Acetaminophen, USP 500 mg

Purpose

Pain reliever/fever reducer

Purpose

Pain reliever/fever reducer

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

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

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 other 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.

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.

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 for more than 10 days unless directed by a doctor
children under 12 years
ask a doctor

Other information

■ store between 20-25°C (68-77°F). See USP Controlled Room Temperature
■ See end panel for lot number and expiration date

Inactive ingredients

hydroxypropyl methyl cellulose, pregelatinized starch, povidone k-30, polyethylene glycol, stearic acid, sodium starch glycolate

Questions or comments?

call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST

EXTRA STRENGTH PAIN RELIEVER ACETAMINOPHEN, USP 500 mg Pain Reliever/Fever Reducer 100 CAPLETS** ** Capsule-Shaped Tablets 500 mg each

[Image in the official label — see DailyMed source]

EXTRA STRENGTH PAIN RELIEVER ACETAMINOPHEN, USP 500 mg Pain Reliever/Fever Reducer 500 CAPLETS 500 mg each

[Image in the official label — see DailyMed source]

DailyMed Set ID: 54899dc4-b49a-2b10-e054-00144ff8d46c · Version 1
NDC: 55315-989