Sleep Aid Capsule, Liquid Filled
FDA Label NDC 83059-0187

16 label sections · Submitted to the FDA by Shield Pharmaceuticals Corp · 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 83059-0187). 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 drug facts, active ingredient (in each softgel), purpose, uses, warnings, ask a  doctor before use if you have, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient (In Each Softgel)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

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

Warnings

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

Otc - When Using

When using this product avoid alcoholic beverages

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

Directions

  • do not take more than directed
  •  take only one dose per day (24 hours)
    •  adults & children 12 years & over take 2 softgels at bedtime if needed or as directed by a doctor
     children under 12 years do 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, isopropyl alcohol, N-butyl alcohol, polyethylene glycol-400, propylene glycol, purified water, shellac, sorbitol solution, titanium dioxide

Questions Or Comments?

1-800-373-6981

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