Topcare Sleep Aid Tablet, Film Coated
FDA Label NDC 36800-431

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare Sleep Aid (NDC 36800-431). 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, use, 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

Use

for relief of occasional sleeplessness

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

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers

When Using This Product

  • avoid alcoholic drinks
  • drowsiness may occur
  • do not drive a motor vehicle or operate machinery

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.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-2222).

Directions

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

  • each caplet contains: calcium 15 mg
  • store at 20-25°C (68-77°F). Avoid high humidity. Protect from light.
  • do not use if blister unit is broken or torn

Inactive Ingredients

carnauba wax, crospovidone, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

Questions Or Comments?

1-888-423-0139

Principal Display Panel

DOES NOT CONTAIN PAIN RELIEVER

Nighttime Sleep Aid

DIPHENHYDRAMINE HCl 25 mg

Helps you fall asleep

Non habit-forming

COMPARE TO SIMPLY SLEEP® NIGHTTIME SLEEP AID active ingredient

actual size

24 CAPLETS

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