Nighttime Sleep Aid
FDA Label NDC 51013-181

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 51013-181). 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, otc - ask doctor/pharmacist, when using this product, 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

Ask A Doctor Before Use If You Have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the 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

Otc - Stop Use

Stop use and ask a doctor if sleeplessness persists 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.

Overdosage

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

Directions

  • take only one dose per day (24 hours)
    • adults and children 12 years and over2 softgels at bedtime if needed or as directed by a doctor
    children under12 yearsdo not use

Other Information

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

Inactive Ingredients

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

Questions Or Comments?

Call toll free: 1-855-215-8180

Principal Display Panel

Nighttime SLEEP-AID

Diphenhydramine HCl 25mg

100 SOFTGELS

Compare to Active Ingredient in VICKS ® ZzzQuil TM NIGHTTIME SLEEP-AID LiquiCaps TM

NDC 51013-181-01

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