FDA Label for Dramamine For Kids

View Indications, Usage & Precautions

Dramamine For Kids Product Label

The following document was submitted to the FDA by the labeler of this product Medtech Products Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


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