Nighttime Sleep Aid Maximum Strength
FDA Label NDC 49035-237

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Equate (walmart Stores, Inc.) for the product Nighttime Sleep Aid Maximum Strength (NDC 49035-237). 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 other, active ingredient (in each softgel), purpose, uses, do not use, ask a doctor before use if you have, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient (In Each Softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Uses

  • for the relief of occasional sleeplessness

Do Not Use

  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin

Ask A Doctor Before Use If You Have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

Directions

  • adults and children 12 years of age and over: take 1 softgel (50 mg) at bedtime if needed, or as directed by adoctor

Other Information

  • store at 15°-30°C (59°-86°F)

Inactive Ingredients

FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special and white edible ink

Questions Or Comments?

Call toll free 1-888-287-1915

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Nighttime Sleep-Aid
Maximum Strength

Diphenhydramine HCl, 50 mg

Compare to Unisom® SleepGels® Active Ingredient*

32 Softgels

NDC 49035-237-16

Distributed by: Wal-Mart Stores, Inc.
Bentonville, AR 72716

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepGels® 

Nighttime Sleep-Aid

Maximum Strength

Diphenhydramine HCl, 50 mg

Compare to Unisom® SleepGels® Active Ingredient*

96 Softgels

NDC 49035-237-96

Distributed by: Wal-Mart Stores, Inc.
Bentonville, AR 72716

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepGels®

* Please review the disclaimer below.