Nighttime Sleep Aid
FDA Label NDC 51013-142

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 51013-142). 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, directions, other information, inactive ingredients, 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

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)
  • Keep outer carton for complete warnings and product information 

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

Nighttime Sleep Aid 32ct Diphenhydramine HCl 50mg compare to the active ingredient in Unisom® Sleep Gels® NDC 51013-142-16

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