DRAMAMINE- dimenhydrinate tablet

Dramamine by

Drug Labeling and Warnings

Dramamine by is a Otc medication manufactured, distributed, or labeled by Navajo Manufacturing Company 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 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 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 1/2 to 1 hour before starting activity
to prevent or treat motion sickness:

• 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 1-1/2 chewable tablets in 24 hours, or as directed by a doctor

Other information

Phenylketonurics: contains phenylalanine 0.75 mg per tablet
store at room temperature 20º-25ºC (68º- 77ºF)
do not use if pouch is opened
see pouch 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

Package Labeling:

INGREDIENTS AND APPEARANCE

DRAMAMINE 
dimenhydrinate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67751-170(NDC:63029-901)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIMENHYDRINATE	50 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ASPARTAME (UNII: Z0H242BBR1)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SORBITOL (UNII: 506T60A25R)

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: 67751-170-01	1 in 1 CARTON	09/23/2016
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 67751-170-02	1 in 1 CARTON	09/23/2016
2		4 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	09/23/2016

Labeler - Navajo Manufacturing Company Inc. (091917799)

Establishment
Name	Address	ID/FEI	Business Operations
Navajo Manufacturing Company Inc.		136941411	relabel(67751-170) , repack(67751-170)