Jet-asleep Double Strength Night Time Sleep Aid Tablet
FDA Label NDC 15579-828

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bell Pharmaceuticals, Inc. for the product Jet-asleep Double Strength Night Time Sleep Aid (NDC 15579-828). 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, do not use, ask a doctor  before use if you have, ask a doctor or pharmacist before useif you are, when using this product, stop use and ask a doctor, 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 50mg

Purpose

Nighttime sleep-aid

Uses

  • 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
  • traouble urinating due to a to enlarged prostate gland
  • glaucome 

Ask A Doctor Or Pharmacist Before Useif You Are

  • taking Sedatives or tranquilizers

When Using This Product

avoid alcoholic drinks

Stop Use And Ask A Doctor

if sleeplessness lasts continuosly 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.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

 adults and children 12 years and over take 1 caplets at bedtime if needed, or as directed by a doctor
 children under 12 years do not ues

Other Information

  • each caplet contains:calcium 35 mg
  • store between 15°-30°C (59°-86°F)
  • don not use if tamper-evident seal is broken or missing

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD & C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, stearic acid

Questions Or Comments?

1-800-328-5890 Weekdays 8:30-5:00 CST

Package Labeling:

Label2 (Label2)

Label2 (Label2)

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