Nighttime Sleep Aid Tablet, Coated
FDA Label NDC 71679-110

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Health Pharma Usa Llc for the product Nighttime Sleep Aid (NDC 71679-110). 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, 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

Uses

provides relief of occasional sleeplessness

Warnings

Do Not Use

  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
  • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

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

  • heart disease

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedative or tranquilizers or any other sleep-aid

When Using This Product

  • drowsiness will occur
  • avoid alcoholic beverages and other drugs that cause drowsiness
  • excitability may occur, especially in children
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving 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.

Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • do not take more than directed (see overdose warning)
  • adults and children 12 years of age and over: - take 2 caplets at bedtime if needed or as directed by a doctor
  • children under 12 years of age: do not use

Other Information

  • Each caplet contains: Calcium 23.52 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • read all product information before using
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive Ingredients

Colloidal silicon dioxide, Croscarmellose sodium, Dicalcium phosphate, FD&C Blue #1, FD&C Blue #2, Magnesium stearate, Microcrystalline cellulose, Polyethylene glycol, Polyvinyl alcohol, Talc, Titanium dioxide

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