Active Ingredients (In Each Geltab)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
The following Structured Product Label (SPL) was submitted to the FDA by Quality Choice (chain Drug Marketing Association) for the product Pain Reliever Pm (NDC 83324-166). 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 ingredients (in each geltab), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Pain reliever
Nighttime sleep-aid
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away
These could be signs of a serious condition.
ask a health professional before use.
Overdose warning: 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.
corn starch, croscarmellose sodium, D&C red #27 aluminum lake, edible black ink, FD&C blue #1 aluminum lake, gelatin, glycerin, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, purified water, silicon dioxide, stearic acid, titanium dioxide
Call1-800-935-2362 Monday-Friday 9AM-5PM EST
*Compare to the Active Ingredient in Extra Strength TYLENOL® PM
Extra Strength
Pain Reliever PM
Pain Reliever | Nighttime Sleep-Aid
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Non-Habit Forming
Geltabs
*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Extra Strength Tylenol® PM.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Distributed by CDMA, Inc.
Novi MI 48375
* Please review the disclaimer below.