Nighttime Sleep Aid Capsule, Liquid Filled
FDA Label NDC 42829-950

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ascent Consumer Products, Inc for the product Nighttime Sleep Aid (NDC 42829-950). 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, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, 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 the relief of occasional sleeplessness
  • reduces time to fall asleep if you have difficulty falling asleep

Warnings

Do not use

for children under 12 years if 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 urniation due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking sedative or tranquilizers

When usiing this product avoid alcoholic beverages

Keep out of reach of children

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 an enlargement of the prostate gland

    • a breathing problem such as emphysema or chronic bronchitis

    glaucoma

    difficulty in urination due to enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers

taking sedative or tranquilizers

When Using This Product

  • avoid alcoholic beverages

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.

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).

Directions

  • take only one dose per day (24 hours)- see overdose warning
    • adults & children 12 yrs & over

    1 softgel(50mg) at bedtime if needed or as directed by a doctor

Other Information

  • store at 20-25 °C (68-77 °F)
  • avoid excessive heat above 40 oC (104 oF)
  • protect from light

Inactive Ingredients

edible dye free ink, gelatin, glycerin, polyethylene glycol, purified water, sorbitol

Questions Or Comments?

1-800-719-9260

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