Nighttime Sleep-aid
FDA Label NDC 51013-104

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Puracap Pharmaceutical Llc for the product Nighttime Sleep-aid (NDC 51013-104). 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 25 mg

Purpose

Nighttime sleep-aid

Uses

  • for the relief of occasional sleeplessness
  • reduces time to fall asleep if you have difficulty falling asleep

Do Not Use

  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
  •  with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

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
  • heart disease

Directions

  • take only one dose per day (24 hours) - see Overdose warning
    •  adults and children 12 years and over ONE dose = TWO 25 mg softgels (50 mg) at bed time if needed or as directed by a doctor                                                              

Other Information

  • store at 15-30° C (59-86° F)
  • avoid excessive heat above 40° C (104° F) and high humidity
  • protect from light

Inactive Ingredients

FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special, and white edible ink

Questions Or Comments?

Call toll free 1-855-215-8180

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Nighttime Sleep-Aid
Diphenhydramine HCl, 25 mg

Compare to Vicks® ZzzQuil® LiquiCaps® Active Ingredient*

12 Softgels

NDC 51013-104-02

Distributed by: Greenbrier International, Inc.

500 Volvo Parkway, Chesapeake, VA 23320

*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® ZzzQuil® LiquiCaps®.

* Please review the disclaimer below.