Active Ingredients (In Each Geltab)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Pain Reliever Pm Tablet, Coated
FDA Label NDC 36800-466
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Top Care (topco Associates Llc) for the product Pain Reliever Pm (NDC 36800-466). 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), purposes, 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.
Label Section Quick Index
Purposes
Pain reliever
Nighttime sleep-aid
Uses
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
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
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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.
- with any other product containing diphenhydramine, even one used on skin
- in children under 12 years of age
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask A Doctor Before Use If You Have
- liver disease
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- glaucoma
Ask A Doctor Or Pharmacist Before Use If You Are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When Using This Product
- drowsiness will occur
- avoid alcoholic drinks
- do not drive a motor vehicle or operate machinery
Stop Use And Ask A Doctor If
- sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
- new symptoms occur
- redness or swelling is present
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
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.
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.
Directions
- do not take more than directed (see overdose warning)
- adults and children 12 years and over: take 2 geltabs at bedtime. Do not take more than 2 geltabs of this product in 24 hours.
- children under 12 years: do not use
Other Information
- store between 20-25°C (68-86°F)
- avoid high humidity and excessive heat
Inactive Ingredients
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
Questions Or Comments?
Call toll free 1-888-423-0139
Principal Display Panel
COMPARE TO EXTRA STRENGTH TYLENOL® PM ACTIVE INGREDIENTS**
EXTRA STRENGTH NIGHTTIME
Pain Relief PM
ACETAMINOPHEN, DIPHENHYDRAMINE HCl, 500/25mg
PAIN RELIEVER / NIGHTTIME SLEEP-AID
Non-Habit Forming
GELTABS For Ages 12 Years and Over
**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 TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
Product Label
TOPCARE HEALTH Extra Strength Pain Relief PM
* Please review the disclaimer below.
