DRAMAMINE ORANGE- dimenhydrinate tablet, chewable

Dramamine Orange by

Drug Labeling and Warnings

Dramamine Orange by is a Otc medication manufactured, distributed, or labeled by Medtech Products Inc., Contract Pharmacal Corp.. 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

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

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) 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

• Phenylketonurics: contains phenylalanine 0.75 mg per tablet
• store at room temperature 20-25ºC (68-77ºF)
• see side panel for lot number and expiration date
• Tamper Evident: Do not use if pouch is torn or open.

• do not use if carton is opened or if blister is broken or torn

Inactive ingredients

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

Questions?

Call 1-800-382-7219

Dramamine® Chewable Orange Motion Sickness Relief, 8 ct

Dramamine® Chewable Orange Motion Sickness Relief, 4 ct

INGREDIENTS AND APPEARANCE

DRAMAMINE ORANGE 
dimenhydrinate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-902
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 CITRIC ACID (UNII: XF417D3PSL)
ASPARTAME (UNII: Z0H242BBR1)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
ALUMINUM OXIDE (UNII: LMI26O6933)
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: 63029-902-01	1 in 1 BOX	01/15/2012
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 63029-902-02	2 in 1 POUCH; Type 0: Not a Combination Product	01/15/2012
3	NDC: 63029-902-04	1 in 1 BOX	03/30/2013
3		4 in 1 BLISTER PACK; 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)