Your browser does not support JavaScript! DRAMAMINE ORANGE (DIMENHYDRINATE) TABLET, CHEWABLE [MEDTECH PRODUCTS INC.]
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RxNorm Names

DRAMAMINE ORANGE (dimenhydrinate) tablet, chewable
[Medtech Products Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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 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 tablets every 4-6 hours
  • do not take more than 8 chewable 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 chewable 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 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 68-77ºF (20-25ºC)
  • do not use if carton is opened or if blister is broken or torn
  • see side panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, aspartame, FD&C yellow #6 aluminum lake, flavors, magnesium stearate, maltodextrin, methacrylic acid copolymer, modified starch, sorbitol

Questions or comments?

Call 1-800-382-7219




PRINCIPAL DISPLAY PANEL

Dimenhydrinate Tablets/Antiemetic
CHEWABLE FORMULA
Dramamine®
MOTION SICKNESS RELIEF
DUAL ACTION
1. TREATS SYMPTOMS ON THE SPOT
2. PREVENTS NAUSEA, DIZZINESS & VOMITING
Convenient Chewable Tablets
8 ORANGE FLAVORED TABLETS (50 mg EACH)

PRINCIPAL DISPLAY PANEL
Dimenhydrinate Tablets/Antiemetic
CHEWABLE FORMULA
Dramamine®
MOTION SICKNESS RELIEF
8 ORANGE FLAVORED TABLETS (50 mg EACH)

DRAMAMINE ORANGE 
dimenhydrinate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 DescriptionMarketing Start DateMarketing End Date
1NDC:63029-902-011 in 1 BOX
18 in 1 BLISTER PACK
2NDC:63029-902-022 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33601/15/2012
Labeler - Medtech Products Inc. (122715688)
Establishment
NameAddressID/FEIBusiness Operations
Contract Pharmacal Corporation057795122ANALYSIS, LABEL, MANUFACTURE, PACK

Revised: 4/2012
 
Medtech Products Inc.

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