DRAMAMINE ORIGINAL FORMULA- dimenhydrinate tablet 
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.

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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:

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 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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

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

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

Questions or comments?

Call 1-800-382-7219

Dramamine.com

PRINCIPAL DISPLAY PANEL

Dramamine®
motion sickness 
Original
Dimenhydrinate tablets/antiemetic
12 tablets (50 mg each)

Dramamine®
motion sickness 
Original 
Dimenhydrinate tablets/antiemetic 
12 tablets (50 mg each)

DRAMAMINE ORIGINAL FORMULA 
dimenhydrinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-901
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMENHYDRINATE (UNII: JB937PER5C) (8-CHLOROTHEOPHYLLINE - UNII:GE2UA340FM) DIMENHYDRINATE50 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColororangeScore2 pieces
ShapeROUNDSize8mm
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-901-013 in 1 BOX01/15/2012
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:63029-901-021 in 1 BOX01/15/2012
212 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:63029-901-031 in 1 CARTON01/15/2012
32 in 1 POUCH; 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: 5/2023
Document Id: 77232753-5c4e-4c55-a53e-e7ad8805b8b1
Set id: f9302a5a-295a-4501-9332-e3f5eb387362
Version: 6
Effective Time: 20230509
 
Medtech Products Inc.