Drug Facts
Active ingredient (in each tablet)
Acetaminophen 500 mg
Acetaminophen Tablet
FDA Label NDC 69842-465
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 69842-465). 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, purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- headache
- the common cold
- backache
- minor pain of arthritis
- toothache
- muscular aches
- 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
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions.
Symptoms may include:
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
- if you are allergic to acetaminophen or any of the inactive ingredients in this product.
acetaminophen, ask a doctor or pharmacist.
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.
Overdosage
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 tablets every 6 hours while symptoms last
■ do not take more than 6 tablets 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: ask a doctor
Other Information
■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
■ see end flap for expiration date and lot number
Inactive Ingredients
povidone, pregelatinized starch, sodium starch glycolate and stearic acid
Questions Or Comments?
1-800-231-4670
Other
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by McNeil
Consumer Healthcare, owner of the registered trademark
Extra Strength Tylenol®.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2018 CVS/pharmacy CVS.com®
1-800-SHOP CVS V-34571
Package Label.Principal Display Panel
CVSHealth
Compare to the active ingredient in Extra Strength Tylenol®*
EXTRA STRENGTH
Acetaminophen
Tablets 500 mg
Pain reliever; Fever reducer
Aspirin free
100 TABLETS
* Please review the disclaimer below.
