Dramamine for Kids

Dosage form: tablet, chewable
Ingredients: DIMENHYDRINATE 25mg
Labeler: Medtech Products Inc.
NDC Code: 63029-904

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Dramamine for Kids

Drug Facts

Active ingredient

(in each tablet)

Dimenhydrinate 25 mg

Purpose

Antiemetic

Use

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

  • nausea
  • vomiting
  • dizziness

Warnings

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 or pharmacist 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 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:
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 under 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 0.84 mg per tablet
  • store at room temperature 68º - 77ºF (20º - 25ºC)
  • do not use if blister is broken or torn

Inactive ingredients

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

Questions?

1-800-382-7219 Dramamine.com






PRINCIPAL DISPLAY PANEL

#1Pharmacist Recommended Brand
Ages 2 – 12

Safe, Precise Dose

Children’s Chewable Formula

Dramamine MOTION SICKNESS RELIEF for Kids

8 Chewable Tablets

Dye Free Grape Flavor

DRAMAMINE FOR KIDS 
dimenhydrinate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-904
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMENHYDRINATE (DIPHENHYDRAMINE) DIMENHYDRINATE25 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME 
CITRIC ACID MONOHYDRATE 
MAGNESIUM STEARATE 
SORBITOL 
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize10mm
FlavorGRAPEImprint CodeDRA
Contains    
Packaging
#Item CodePackage Description
1NDC:63029-904-011 CASE (1 CASE) in 1 BLISTER PACK
18 TABLET, CHEWABLE (8 TABLET) in 1 CASE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33602/15/2012
Labeler - Medtech Products Inc. (122715688)
Establishment
NameAddressID/FEIOperations
Contract Pharmacal Corporation057795122MANUFACTURE(63029-904)

Revised: 04/2012
 
Medtech Products Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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