Nighttime Sleep Aid
FDA Label NDC 36800-654

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 36800-654). 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, warnings, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, 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 relief of occasional sleeplessness

Warnings

Warnings

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

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When Using This Product

avoid alcoholic drinks

Stop Use And Ask A Doctor If

sleeplessness persist continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. 1(800)222-1222

Directions

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

Inactive Ingredients

FD&C Blue#1, gelatin, glycerin, polyethylene glycol-400, propylene glycol, sorbitol, titanium dioxide, water

Questions Or Comments?

1-888-333-9792

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TOPCARE HEALTH™

Compare to  UNISOM® SLEEPGELS®active ingredient*

NIGHTTIME MAXIMUM STRENGTH

SLEEP-AID

DIPHENHYDRAMINE HCl 50 mg

NIGHTTIME SLEEP-AID

  • Fall Asleep Fast
  • Sleep Soundly
  • Wake Refreshed
  • Safe/Non-Habit Forming 

    • 96 SOFTGELS**

    **LIQUID-FILLED CAPSULES

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    Image Description (Untitled)

* Please review the disclaimer below.