Dramamine For Kids Tablet, Chewable
FDA Label NDC 63029-910

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 63029-910). 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 for, ask a doctor before use if the child has, ask a doctor before use if the child is, 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 25 mg

Purpose

Antiemetic 

Use

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

nausea dizziness vomiting

Do Not Use For

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
  • Avoid alcoholic drinks
  • Alcohol, sedatives, and tranquilizers may increase drowsiness
  • Be careful when dricing a motor vehicle or opereating 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 Contorl 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:

    • Children 2 to under 6 years

    • Give ½ to 1 chewable tablet every 6-8 hours
    • Do not five more than 3 chewable tablets in 24 hours or as directed by a doctor

      • Children 6 to 12 years

      • Give 1 to 2 chewable talets 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 0.38 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

Principal Display Panel

Children’s Chewable Formula

Dramamine ®

Dimenhydrinate 25 mg/ Antiemetic

8 Chewable Tablets             Travel case

Children’s Chewable Formuladramamine ® Dimenhydrinate 25 mg/ Antiemetic8 Chewable Tablets Travel Case (Dramamine Tablets Chewable For Kids 01)

Children’s Chewable Formuladramamine ® Dimenhydrinate 25 mg/ Antiemetic8 Chewable Tablets Travel Case (Dramamine Tablets Chewable For Kids 01)

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