Equate Nighttime Sleep Aid Tablet, Film Coated
FDA Label NDC 79903-274

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walmart Inc. for the product Equate Nighttime Sleep Aid (NDC 79903-274). 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 caplet), purpose, uses, 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, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Caplet)

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives 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 (2 caplets) per day (24 hours)

    • adults and children 12 years and over

    take 2 caplets 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)
  • do not use if printed seal under cap is broken or missing

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 3350, polyvinyl alcohol, pregelatinized starch, stearic acid, talc, titanium dioxide

Questions Or Comments?

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equate™

Compare to Vicks® ZzzQuil® active ingredient

NIGHTTIME

Sleep-Aid

Diphenhydramine HCl, 25 mg

Nighttime Sleep-Aid

Actual Size

• Non-habit forming

• Not for treating cold and flu

25 mg EACH

365 CAPLETS

57p-2e-nighttime-sleep-aid.jpg (57p 2e Nighttime Sleep Aid)

57p-2e-nighttime-sleep-aid.jpg (57p 2e Nighttime Sleep Aid)

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