DRAMAMINE- dimenhydrinate tablet

Dramamine by

Drug Labeling and Warnings

Dramamine by is a Otc medication manufactured, distributed, or labeled by Select Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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) immediately.

Directions

• to prevent motion sickness, the first dose should be taken 1/2 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 chewable 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 1/2 to 1 chewable 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 1/2 chewable tablet every 6-8 hours
  • do not give more than 1½ chewable tablets in 24 hours, or as directed by a doctor

Other information

• Phenylketonurics: contains phenylaline 0.84 mg per tablet
• store at room tempurature 20°- 25°C (68°-77°F)
• do not use if pouch is opened
• see bottom of this 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

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Dist By:
Medtech Products, Inc. Tarrytown, NY 10591

Product Repackaged and Distributed
with permission of manufacturer by:
Select Corporation Carrollton, TX 75007

PRINCIPAL DISPLAY PANEL - 50 mg Tablet Packet Carton

#1
Pharmacist
Recommended
BRAND

DIMENHYDRINATE
TABLETS / ANTIEMETIC

Dramamine®

motion sickness

CHEWABLE

Dual Action:

Prevents & Relieves Nausea,
Dizziness and Vomiting

TO OPEN
PUSH IN TAB AND PULL OUT

25 Packets of 2 Orange Flavor Tablets
(50 mg each)

INGREDIENTS AND APPEARANCE

DRAMAMINE 
dimenhydrinate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52904-962(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
silicon dioxide (UNII: ETJ7Z6XBU4)
croscarmellose sodium (UNII: M28OL1HH48)
lactose, unspecified form (UNII: J2B2A4N98G)
magnesium stearate (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (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: 52904-962-04	1 in 1 BLISTER PACK	01/15/2012
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 52904-962-25	25 in 1 CARTON	01/15/2012
2		2 in 1 POUCH; 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 - Select Corporation (053805599)