Nighttime Sleep Aid Tablet
FDA Label NDC 37835-812

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bi-mart for the product Nighttime Sleep Aid (NDC 37835-812). 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, 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 Caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Use

help reduce difficult falling asleep

Warnings

Do Not Use

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

Ask A Doctor Before Use If You Have

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.

When Using This Product

  • avoid alcoholic beverages
  • be careful when driveing a motor 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 a serious underlying medical illness.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

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

Directions

  • adults and children 12 years of age and older: take 2 caplets at bedtime if needed or as directed by a doctor

Other Information

  • each caplet contains:calcium 30 mg

  • each caplet contains:phosphorus 15 mg

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

  • protect from moisture

Inactive Ingredients

Briliant Blue Lack, Colloidal Silicon Dioxide, Croscarmellose Sodium, Dicalcium Phosphate, Indigo Carmine Lake, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Stearic Acid, Talc, Titanium Dioxide

Questions?

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