Nighttime Sleep Aid
FDA Label NDC 36800-413

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Nighttime Sleep Aid (NDC 36800-413). 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 ingredient (in each softgel), purpose, use, do not use, ask a doctor before use if you have, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Use

  • for 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

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

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

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?

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Principal Display Panel

TopCare Nighttime Sleep Aid

Diphenhydramine HCl 50 mg  96SOFTGELS

NDC 36800-413-96

*Compare to the active ingredient in Unisom® SleepGels®

* Please review the disclaimer below.