Active Ingredient (In Each Caplet)
Acetaminophen USP, 500 mg
Acetaminophen Tablet
FDA Label NDC 75907-429
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dr. Reddy's Laboratories Inc. for the product Acetaminophen (NDC 75907-429). 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, allergy alert:, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, 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:
■ the common cold
■ headache
■ 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
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 of the 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
Keep Out Of Reach Of Children
Keep out of reach of children
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 bottom panel for lot number and expiration date
Inactive Ingredients
hydroxypropyl methyl cellulose, polyethylene glycol, povidone k-30, pregelatinized starch, sodium starch glycolate, stearic acid
Questions Or Comments?
call 1-888-375-3784 weekdays (8:00 AM to 8:00 PM EST )
Other
Distributed by:
Dr. Reddy’s Laboratories Inc.,
Princeton, NJ 08540
Made in India
Rev: 06/26
*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Tylenol® Extra Strength Caplets. Tylenol® is a registered trademark of Kenvue Inc.
Principal Display Panel
NDC 75907-429-02
Extra Strength
Acetaminophen USP, 500 mg
Pain Reliever/ Fever Reducer
For Adults
200 Caplets**
500 mg each (**Capsule-Shaped Tablets)
*Compare to the active ingredient in Tylenol Extra Strength Caplets
IMPORTANT: READ THE DIRECTIONS AND WARNINGS BEFORE USE
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
* Please review the disclaimer below.
