Nighttime Sleep Aid Tablet
FDA Label NDC 83324-110

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association, Inc. for the product Nighttime Sleep Aid (NDC 83324-110). 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 other, active ingredient (in each tablet), purpose, use, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient (In Each Tablet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Use

helps to reduce difficulty falling asleep

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
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers

Otc - When Using

When using this product

  • avoid alcoholic drinks
  • drowsiness will occur
  • do not drive a motor vehicle or operate machinery

Otc - Stop Use

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.

Keep Out Of Reach Of Children.

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 of age and over: take two tablets at bedtime if needed, or as directed by a doctor
  • children under 12 years of age:  do not use

Other Information

  • each tablet contains:calcium 85 mg
  • store between 20-25°C (68-77°F)
  • retain carton for complete product information

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose

Principal Display Panel

QUALITY CHOICE®

NDC 83324-110-32

†Compare to Active Ingredient in SOMINEX® Tablets

Nighttime Sleep Aid

Diphenhydramine HCl 25 mg

Nighttime Sleep-Aid

Does NOT Contain Pain Reliever

32 TABLETS

Actual Size

Image Description (F101902qch R3)

Image Description (F101902qch R3)

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