Dramamine Less Drowsy Tablet
FDA Label NDC 63029-903

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medtech Products Inc. for the product Dramamine Less Drowsy (NDC 63029-903). 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, purpose, use, 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, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

(in each tablet)

Meclizine HCI 25 mg

Purpose

Antiemetic

Use

for prevention and treatment of these symptoms associated with motion sickness:

  • nausea
  • vomiting
  • dizziness

Do Not Use

for children under 12 years of age unless directed by a doctor

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

  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

If Pregnant Or Breast-Feeding,

ask a doctor before use.

Keep Out Of Reach Of Children.

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

Directions

  • take first dose one hour before starting activity
  • adults and children 12 years and over: 1 to 2 tablets once daily, or as directed by a doctor

Other Information

  • store between 20 - 25°C (68 - 77°F)
  • do not use if blister is broken or torn

Inactive Ingredients

anhydrous lactose, corn starch, colloidal silicon dioxide, D&C yellow # 10 aluminum lake, magnesium stearate, microcrystalline cellulose

Questions Or Comments?

call 1-800-382-7219

Principal Display Panel

Meclizine hydrochloride tablets/Antiemetic
Dramamine®
LESS DROWSY FORMULA
Provides Up To 24 Hours of Motion Sickness Protection
Protection With Less Drowsiness!
8 TABLETS (25 mg EACH)

Principal Display Panelmeclizine Hydrochloride Tablets/antiemeticdramamine®8 Tablets (25 mg Each) (Dramamine Less Drowsy 01)

Principal Display Panelmeclizine Hydrochloride Tablets/antiemeticdramamine®8 Tablets (25 mg Each) (Dramamine Less Drowsy 01)

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