Active Ingredients (In Each Geltab)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
The following Structured Product Label (SPL) was submitted to the FDA by United Natural Foods, Inc. Dba Unfi for the product Acetaminophen Pm (NDC 41163-228). 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, sodium starch glycolate*, stearic acid, titanium dioxide
*contains one or more of these ingredients
Call toll free 1-877-932-7948
Compare to Extra Strength Tylenol® PM active ingredients†
Extra Strength
Acetaminophen PM
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Pain reliever/nighttime sleep-aid
Non-habit Forming
Geltabs
†This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Extra Strength Tylenol® PM.
DISTRIBUTED BY SUPERVALU INC.
EDEN PRAIRIE, MN 55344 USA
supervaluprivatebrands.com
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
* Please review the disclaimer below.