Acetaminophen
- Dosage form
- TABLET
- Labeler
- CVS PHARMACY, INC
- Label updated
- 2025-12-19
- Retrieved
- 2026-09-07
- Active ingredients
- ACETAMINOPHEN
Active ingredient
(in each Gelcap)
Acetaminophen, USP 500 mg
Purpose
Pain reliever/fever reducer
Uses
■ temporarily relieves minor aches and pains due to:
■ headache
■ muscular aches
■ backache
■ minor pain of arthritis
■ toothache
■ the common cold
■ 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 have ever had an allergic reaction to this product or any of its ingredients
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 the reach of children.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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
adults and children 12 years and over
■ take 2 gelcaps every 6 hours while symptoms last
■ do not take more than 6 gelcaps in 24 hours, unless directed by a doctor
■ do not take more than 10 days unless directed by a doctor
children under 12 years
■ ask a doctor
Other information
■ store at 20°-25°C (68°-77°F). See USP Controlled Room Temperature
■ avoid high humidity
■ see end panel for lot number and expiration date
Inactive ingredients
ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, D&C red#33, FD&C blue#1, FD&C red#40, FD&C yellow#6, gelatin, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, hypromellose, iron oxide red, isopropyl alcohol, n-butyl alcohol, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide, yellow iron oxide.
Questions or comments?
call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.
Acetaminophen, USP 500 mg Rapid Release Gelcaps
[Image in the official label — see DailyMed source]
DailyMed Set ID: c2c6d6a1-b492-506d-e053-2995a90aac23 · Version 8
NDC: 69842-491