Dramamine For Kids Tablet, Chewable
FDA Label NDC 63029-908

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 For Kids (NDC 63029-908). 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 tablet), purpose, use, warnings, ask a doctor before use if the child has, ask a doctor before use if the child is, when using this product, keep out of reach of children., 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 25mg

Purpose

Antiemetic

Use

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

  • nausea
  • dizziness
  • vomiting

Warnings

Do not give to children under 2 years of age unless directed by a doctor.

Ask A Doctor Before Use If The Child Has

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma

Ask A Doctor Before Use If The Child Is

taking sedatives or tranquilizers

When Using This Product

  • marked drowsiness may occur
  • sedatives, and tranquilizers may increase drowsiness

Keep Out Of Reach Of Children.

In case of accidental 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:
    • Children 2 to under 6 years Give ½ to 1 chewable tablet every 6-8 hours 
      • Do not give more than 3 chewable tablets in 24 hours or as directed by a doctor

        • Children 6 to 12 years

        • Give 1 to 2 chewable tablets every 6-8 hours
        • Do not give more than 6 chewable tablets in 24 hours, or as directed by a doctor

Other Information

  • Phenylketonurics: contains phenylalanine 0.42 mg per tablet
  • Store at room temperature 20◦-25◦C (68◦-77◦F)
  • Do not use if blister is broken or torn

Inactive Ingredients

aspartame, citric acid, flavors, magnesium stearate, methacrylic acid copolymer, sorbitol

Questions?

1-800-382-7219 Dramamine.com

Dist. by Medtech Products Inc., Tarrytown, NY 10591
A Prestige Consumer Healthcare company.
Made in Italy
©2024 Trade dress is owned by Medtech Products Inc. All rights reserved.
DAUS092101

Principal Display Panel

Dramamine®
motion sickness
for Kids
CHEWABLE
DYE FREE
8 CHEWABLE TABLETS            
GRAPE FLAVOR

Dramamine® Motion Sicknessfor Kidschewabledye Free8 Chewable Tablets Grape Flavor (Dramamine Chewable Tablets For Kids Grape 01)

Dramamine® Motion Sicknessfor Kidschewabledye Free8 Chewable Tablets Grape Flavor (Dramamine Chewable Tablets For Kids Grape 01)

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