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Dramamine Orange

Medically reviewed on Dec 6, 2017

Dosage form: tablet, chewable
Ingredients: DIMENHYDRINATE 50mg
Labeler: Medtech Products Inc.
NDC Code: 63029-902

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® Chewable Orange Motion Sickness Relief

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

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 20-25ºC (68-77ºF)
  • 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

Dramamine® Chewable Orange Motion Sickness Relief, 8 ct

Dramamine® Chewable Orange Motion Sickness Relief, 4 ct

DRAMAMINE ORANGE 
dimenhydrinate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-902
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMENHYDRINATE (CHLORTHEOPHYLLINE) DIMENHYDRINATE50 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
ASPARTAME 
FD&C YELLOW NO. 6 
ALUMINUM OXIDE 
MAGNESIUM STEARATE 
MALTODEXTRIN 
SORBITOL 
Product Characteristics
ColororangeScore2 pieces
ShapeROUNDSize12mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63029-902-011 BLISTER PACK in 1 BOX
18 TABLET, CHEWABLE in 1 BLISTER PACK
2NDC:63029-902-022 TABLET, CHEWABLE in 1 POUCH
3NDC:63029-902-041 BLISTER PACK in 1 BOX
34 TABLET, CHEWABLE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33601/15/2012
Labeler - Medtech Products Inc. (122715688)

 
Medtech Products Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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