Active Ingredients (In Each Gelcap)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
The following Structured Product Label (SPL) was submitted to the FDA by Foodhold U.s.a., Llc for the product Acetaminophen Pm (NDC 41520-956). 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 gelcap), 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.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, FD&C red #3, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, simethicone, stearic acid, titanium dioxide
1-800-426-9391
CAREone®
NDC 41520-956-31
Compare to the active ingredients in Extra Strength Tylenol® PM*
Extra Strength
ACETAMINOPHEN PM
Acetaminophen, 500 mg
Diphenhydramine HCl, 25 mg
Pain Reliever
Nighttime Sleep Aid
Non-habit forming
Rapid Release
80 GELCAPS
Actual Size
OUR PHARMACISTS
Rx
RECOMMEND
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This Product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Extra Strength Tylenol® PM.
50844 ORG041755631
DISTRIBUTED BY
FOODHOLD U.S.A., LLC
LANDOVER, MD 20785
1-877-846-9949 ©2018 S&S Brands, LLC
Quality guaranteed or your money back.
* Please review the disclaimer below.