Dramamine Original Formula Tablet
FDA Label NDC 63029-901

14 label sections · Submitted to the FDA by Medtech Products Inc. · 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 Original Formula (NDC 63029-901). 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 give to, 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)

Dimenhydrinate 50 mg

Purpose

Antiemetic

Use

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

  • nausea
  • vomiting
  • dizziness

Do Not Give To

children under 2 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

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase dizziness
  • 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) immediately.

Directions

  • to prevent motion sickness, the first dose should be taken ½ to 1 hour before starting activity
  • to prevent or treat motion sickness, see below:
    • Adults and
    children 12
    years and over
    • take 1 to 2 tables every 4-6 hours
    • do not take more than 8 tablets in
      24 hours, or as directed by a doctor
    Children 6 to
    under 12 years
    • give ½ to 1 tablet every 6-8 hours
    • do not give more than 3 tablets in
      24 hours, or as directed by a doctor
    Children 2 to
    under 6 years
    • give ½ tablet every 6-8 hours
    • do not give more than 1 ½ tablets
      in 24 hours, or as directed by a doctor

Other Information

  • store at room temperature 20-25°C (68-77°F) 

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose

Questions Or Comments?

Call 1-800-382-7219

Dramamine.com

Principal Display Panel

Dramamine®
motion sickness 
Original
Dimenhydrinate tablets/antiemetic
12 tablets (50 mg each)

Dramamine®motion Sickness Original Dimenhydrinate Tablets/antiemetic 12 Tablets (50 mg Each) (Dramamine Original Formula 01)

Dramamine®motion Sickness Original Dimenhydrinate Tablets/antiemetic 12 Tablets (50 mg Each) (Dramamine Original Formula 01)

Dramamine®
motion sickness
Original
Dimenhydrinate tablets/antiemetic
36 tablets (50 mg each)

A Yellow Label With A Blue Circle And White Textai-generated Content May Be Incorrect. (Dramamine Original Formula 02)

A Yellow Label With A Blue Circle And White Textai-generated Content May Be Incorrect. (Dramamine Original Formula 02)

* Please review the disclaimer below.