Dramamine Orange Tablet, Chewable
FDA Label NDC 63029-902

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 Orange (NDC 63029-902). 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, purpose, use, warnings, do not give to, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are taking, 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)

Dimenhydrinate 50 mg

Purpose

Antiemetic

Use

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

  • nausea
  • vomiting
  • dizziness

Warnings

Warnings

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

taking sedatives or tranquilizers

When Using This Product

  • marked 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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

  • Phenylketonurics: contains phenylalanine 0.75 mg per tablet
  • store at room temperature 20-25°C (68-77°F)
  • see side panel for lot number and expiration date
  • Tamper Evident: Do not use if pouch is torn or open.

  • do not use if carton is opened or if blister is broken or torn

Inactive Ingredients

anhydrous citric acid, aspartame, FD&C yellow no. 6 aluminum lake, flavors, magnesium stearate, maltodextrin, methacrylic acid copolymer, modified food starch, sorbitol

Questions?

Call 1-800-382-7219

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