Sleep Aid Capsule, Liquid Filled
FDA Label NDC 83059-0022

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Shield Pharmaceuticals Corp for the product Sleep Aid (NDC 83059-0022). 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 ingredients (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 Ingredients (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

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 asthma, emphysema, or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • heart disease

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you aretaking sedatives, tranquilizers or any other sleep aid

When Using This Product

  • avoid alcoholic beverages and other drugs that cause drowsiness
  • drowsiness will occur
  • be careful when driving a motor vehicle or operating machinery

Otc - Stop Use

Stop use and ask a doctor ifsleeplessness 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.Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. 1(800)222-1222

Directions

  • do not take more than directed
  • take only one dose per day (24 hours)
    • adults & children 12 yrs & overtake 2 capsules at bedtime if needed or as directed by a doctor
    children under 12 yearsDo not use

Other Information

  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F) and high humidity
  • Protect from light

Inactive Ingredients

FD&C Blue No. 1, FD&C Red No. 40, gelatin, glycerin, propylene glycol, polyethylene glycol-400, povidone, purified water, sorbitol sorbitan solution

Questions Or Comments?

1-800-373-6981

Otc - Questions

Distributed by:
Shield Pharmaceuticals Corp.
Hauppauge, NY 11788

Principal Display Panel

SLEEP-AID

DIPHENHYDRAMINE HCl 25 mg

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