Active Ingredient (In Each Caplet)
Acetaminophen 500 mg
Acetaminophen Tablet, Film Coated
FDA Label NDC 68196-031
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sam's West Inc for the product Acetaminophen (NDC 68196-031). 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 active ingredient (in each caplet), 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
- muscular aches
- the common cold
- backache
- toothache
- minor pain from 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
- rash
- skin reddening
- blisters
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 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
- redness or swelling is present
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- any new symptoms appear
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center 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 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: ask a doctor
Other Information
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- use by expiration date on package
Inactive Ingredients
castor oil, hypromellose, povidone, sodium starch glycolate, starch, stearic acid
Questions Or Comments?
1-800-426-9391
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COMPARE TO EXTRA STRENGTH
TYLENOL® CAPLETS ACTIVE INGREDIENT*
M
Member's
Mark™
NDC 68196-031-06
EXTRA STRENGTH
Acetaminophen
500 mg CAPLETS
Pain Reliever/Fever Reducer
600 CAPLETS**
(**CAPSULE SHAPED TABLETS)
ACTUAL SIZE
FOR ADULTS
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by Kenvue Inc., owner of the registered
trademark Extra Strength Tylenol® Caplets. 50844 ORG102417578
DISTRIBUTED BY: SAM'S WEST, INC., BENTONVILLE, AR 72716
Members Mark 44-175 (Members Mark 44 175 1)
* Please review the disclaimer below.
