DRAMAMINE CHEWABLE DIMENHYDRINATE- dimenhydrinate tablet, chewable

Dramamine Chewable Dimenhydrinate by

Drug Labeling and Warnings

Dramamine Chewable Dimenhydrinate by is a Otc medication manufactured, distributed, or labeled by JC World Bell Wholesale Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 givetochildren under 12 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 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 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 ½ 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 ½ chewable 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 20-25ºC (68-77ºF)
• see side panel for lot number and expiration date

Inactive ingredients

anhydrous-citric-acid, aspartame, FD&C yellow no. 6 aluminum lake, flavors, magnesium stearate, maltodextrin, methacrylic acid copolymer, modified starch, sorbitol

Questions?

1-800-382-7219 Dramamine.com

Package Labeling:

INGREDIENTS AND APPEARANCE

DRAMAMINE CHEWABLE DIMENHYDRINATE 
dimenhydrinate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50269-525(NDC:63029-902)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMENHYDRINATE (UNII: JB937PER5C) (8-CHLOROTHEOPHYLLINE - UNII:GE2UA340FM)	DIMENHYDRINATE	50 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ASPARTAME (UNII: Z0H242BBR1)
FD&C YELLOW NO. 6 ALUMINUM LAKE (UNII: GYP6Z2JR6Q)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	orange	Score	2 pieces
Shape	ROUND	Size	12mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50269-525-00	2 in 1 BOX	01/15/2012
1		20 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M009	01/15/2012

Labeler - JC World Bell Wholesale Co., Inc. (805257581)

Registrant - JC World Bell Wholesale Co., Inc. (805257581)

Establishment
Name	Address	ID/FEI	Business Operations
JC World Bell Wholesale Co., Inc.		805257581	repack(50269-525)