Drug Facts
Active ingredient (in each caplet)
Acetaminophen 500 mg
Acetaminophen Tablet, Film Coated
FDA Label NDC 69842-864
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy, Inc for the product Acetaminophen (NDC 69842-864). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, otc - purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Pain reliever/fever reducer
Uses
temporarily relieves minor aches and pains due to the common cold headache toothache
muscular aches
backache
minor pain of arthritis
premenstrual and menstrual cramps
temporarily reduces fever
Warnings
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.
Otc - 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
Otc - Ask Doctor
Ask a doctor before use if you have liver disease
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Otc - Stop Use
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
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 of age 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 take for more than 10 days unless directed by a doctor |
| children under 12
years of age | ask a doctor |
Other Information
Store in a dry place at 15° – 30°C (59° – 86°F)
Inactive Ingredient
corn starch, hypromellose, mineral oil, polyethylene glycol, povidone, sodium lauryl sulfate, sodium starch glycolate, stearic acid, talc, titanium dioxide
Questions Or Comments?
Call 1-800-231-4670
Other
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2021 CVS/pharmacy
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol®.
DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING
Package Label.Principal Display Panel
CVS Health
Compare to the active ingredient in Extra Strength Tylenol®*
Extra Strength
Acetaminophen
Caplets 500 mg
Pain reliever; Fever reducer
1000 Caplets
* Please review the disclaimer below.
