Nighttime Sleep Aid
FDA Label NDC 68210-4132

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Spirit Pharmaceuticals Llc for the product Nighttime Sleep Aid (NDC 68210-4132). 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 other, active ingredients (in each caplet), purpose, uses, warnings, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredients (In Each Caplet)

Diphenhydramine HCl 25mg

Purpose

nighttime sleep-aid

Uses

for the relief of occasional sleeplessness

Warnings

Warnings

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
  • trouble urinating due to an enlarged prostate gland

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When Using This Product

  • avoid alcoholic drinks
  • drowsiness will 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.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdose Warning

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

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 25 mg

store between 20-25°C(68-77°F). Avoid high humidity. Protect from light.

Inactive Ingredients

Colloidal siicon dioxide, croscarmellose sodium, dicalcium phosphate, FD&C Blue#1, FD&C Blue#2, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Questions Or Comments?

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