Nightime Sleep Aid
FDA Label NDC 58805-006

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Agile Pharmachem for the product Nightime Sleep Aid (NDC 58805-006). 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, purpose, uses, directions, warnings, keep out of reach of children., 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

Uses

  • For relief of occasional sleeplessness.

Directions

  • adults and children 12 years and over : one softgel (50 mg) at bed time if needed or as directed by a doctor.
  • children under 12 years:do not use

Warnings

Do not use

  • in 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

  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

    When using this product

  • avoid alcoholic drinks

    If pregnant or breast-feeding, ask a health professional before use.

Keep Out Of Reach Of Children.

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

Other Information

  • save carton for full directions and warnings

Inactive Ingredients

Blue 1, gelatin, glycerin, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, sorbitol, titanium dioxide and water.

Questions Or Comments

Call 1-855-314-1850

Package Label.Principal Display Panel

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7898db8a-figure-01 (7898db8a Figure 01)

DIPHENHYDRAMINE HYDROCHLORIDE SOFTGEL CAPSULE, USP 50 MG

NDC:58805-006-02 

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