DRAMAMINE ORANGE- dimenhydrinate tablet, chewable 
Medtech Products Inc.

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:

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

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

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 8 ct Carton

Dramamine® Chewable Orange Motion Sickness Relief, 4 ct

Dramamine Chewable Orange 4 ct Carton

DRAMAMINE ORANGE 
dimenhydrinate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-902
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMENHYDRINATE (UNII: JB937PER5C) (CHLORTHEOPHYLLINE - UNII:GE2UA340FM) DIMENHYDRINATE50 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ASPARTAME (UNII: Z0H242BBR1)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColororangeScore2 pieces
ShapeROUNDSize12mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-902-011 in 1 BOX01/15/2012
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:63029-902-022 in 1 POUCH; Type 0: Not a Combination Product01/15/2012
3NDC:63029-902-041 in 1 BOX03/30/2013
34 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33601/15/2012
Labeler - Medtech Products Inc. (122715688)

Revised: 12/2017
Document Id: 7d7edc5c-4edc-4e91-9cb4-dfb5f60f99ea
Set id: 76166156-bce1-492f-833e-6bbd07859c3f
Version: 4
Effective Time: 20171206
 
Medtech Products Inc.