Nytol Tablet
FDA Label NDC 63029-211

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medtech Products Inc. for the product Nytol (NDC 63029-211). 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, use, warnings, ask a doctor or pharmacist before use if you are, ask a doctor before use if you have, 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

Diphenhydramine HCl, 25 mg

Purpose

Nighttime sleep-aid

Use

relieves occasional sleeplessness

Warnings

Do not use

  • in children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
  • with other antihistamines

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers

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

When Using This Product

  • avoid alcoholic beverages
  • be careful when driving a moter vehicle or operating 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 care professional before use.

Keep Out Of Reach Of Children.

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

Directions

  • adults and children 12 years of age and over: take 2 caplets (50 mg) at bedtime if needed, or as directed by a doctor
  • children under 12 years: do not use

Other Information

  • each caplot contains: calcium 12 mg
  • store at 20°-25°C (68°-77°F)

Inactive Ingredients

crosscarmellose sodium, dicalcium phosphate, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, mineral oil, silica, stearic acid, talc, titanium dioxide, tracetin

Principal Display Panel

Nytol QuickCaps with Diphenhydramine HCl

Nighttime Sleep-Aid

32 caplets

Nytol Quickcaps 32 Count Carton (Nytol 01)

Nytol Quickcaps 32 Count Carton (Nytol 01)

Principal Display Panel

Nytol QuickCaps with Diphenhydramine HCl

Nighttime Sleep-Aid

16 caplets

Nytol Quickcaps 16 Count Carton (Nytol 02)

Nytol Quickcaps 16 Count Carton (Nytol 02)

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