AcetaminophenExtra Strength
- Dosage form
- TABLET
- Labeler
- Dr. Reddy's Laboratories Inc.
- Label updated
- 2026-06-12
- Retrieved
- 2026-09-07
- Active ingredients
- ACETAMINOPHEN
Active ingredient (in each caplet)
Acetaminophen USP, 500 mg
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 )
SPL UNCLASSIFIED SECTION
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
[Image in the official label — see DailyMed source]
DailyMed Set ID: 9769e0c0-2f4c-3b7a-1a65-c98fbce11681 · Version 1
NDC: 75907-429