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Dramamine Original Formula

Dosage form: tablet
Ingredients: DIMENHYDRINATE 50mg
Labeler: Medtech Products Inc.
NDC Code: 63029-901

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 Original Formula

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 use

for 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 dizziness
  • 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
  • store at room temperature 68-77ºF (20-25ºC)
  • do not use if carton is open or if blister unit is broken or torn
  • see side panel for lot number and expiration date

Inactive ingredients

anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose

Questions or comments?

Call 1-800-382-7219





PRINCIPAL DISPLAY PANEL

Dimenhydrinate Tablets/Antiemetic
ORIGINAL FORMULA Dramamine®
MOTION SICKNESS RELIEF
DUAL ACTION
1. TREATS SYMPTOMS ON THE SPOT
2. PREVENS NAUSEA, DIZZINESS & VOMITING
36 Tablets (50 mg EACH)

DRAMAMINE ORIGINAL FORMULA 
dimenhydrinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-901
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMENHYDRINATE (CHLORTHEOPHYLLINE) DIMENHYDRINATE50 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
Product Characteristics
ColorORANGEScore2 pieces
ShapeROUNDSize8mm
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63029-901-013 BLISTER PACK (3 BLISTER) in 1 BOX
112 TABLET (12 TABLET) in 1 BLISTER PACK
2NDC:63029-901-021 BOTTLE (1 BOTTLE) in 1 BOX
212 TABLET (12 TABLET) in 1 BOTTLE
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.

Medically reviewed on Apr 13, 2018

Further information

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

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