DRAMAMINE ORIGINAL FORMULA- dimenhydrinate tablet

Dramamine Original Formula by

Drug Labeling and Warnings

Dramamine Original Formula by is a Otc medication manufactured, distributed, or labeled by Medtech Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

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

Questions or comments?

Call 1-800-382-7219

PRINCIPAL DISPLAY PANEL

ORIGINAL FORMULA

Dramamine®
Dimenhydrinate Tablets/Antiemetic

MOTION SICKNESS RELIEF

12 Tablets (50 mg EACH)

ORIGINAL FORMULA

Dramamine®
Dimenhydrinate Tablets/Antiemetic

MOTION SICKNESS RELIEF 

36 Tablets (50 mg EACH)

INGREDIENTS AND APPEARANCE

DRAMAMINE ORIGINAL FORMULA 
dimenhydrinate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-901
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMENHYDRINATE (UNII: JB937PER5C) (CHLORTHEOPHYLLINE - UNII:GE2UA340FM)	DIMENHYDRINATE	50 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	ORANGE	Score	2 pieces
Shape	ROUND	Size	8mm
Flavor	ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-901-01	3 in 1 BOX	01/15/2012
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 63029-901-02	1 in 1 BOX	01/15/2012
2		12 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part336	01/15/2012

Labeler - Medtech Products Inc. (122715688)