Active Ingredient (In Each Tablet)
Acetaminophen 500 mg
The following Structured Product Label (SPL) was submitted to the FDA by Lil' Drug Store Products, Inc. for the product Extra Strength Pain Reliever (NDC 29485-9281). 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 tablet), purpose, uses, liver warning, allergy alert, do not use, ask a doctor before use if you have, ask a doctor before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 500 mg
Pain reliever/fever reducer
This product contains acetaminophen. The maximum daily dose of this product is 6 tablets (3,000 mg) in 24 hours.
Severe liver damage may occur if you take
:acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
liver disease
taking the blood thinning drug warfarin
These could be signs of a serious condition.
ask a health professional before use.
Overdose warning
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
| adults and children 12 years and over |
|
| children under 12 years | ask a doctor |
corn starch, hypromellose, maltodextrin
may contain
, microcrystalline cellulosecall toll-free 1-800-351-2000 (M-F 8:00 AM-4:30 PM CST)
*This product is not manufactured or distributed by JOHNSON & JOHNSON, INC., McNeil Consumer Healthcare Division,
distributor of Tylenol® Extra Strength.
Manufactured for:
Lil' Drug Store products, Inc.
9300 Earhart Lane SW
Cedar Rapids, IA 52404
COMPARE TO THE ACTIVE INGREDIENT IN
Tylenol® Extra Strength*
Extra Strength
Pain Reliever
Acetaminophen 500mg
Pain Reliever/Fever Reducer
actual size [pill image]
2 TABLETS PER POUCH
* Please review the disclaimer below.