Dramamine (Dimenhydrinate) Tablet [Navajo Manufacturing Company Inc.] -

DRAMAMINE (DIMENHYDRINATE) TABLET [NAVAJO MANUFACTURING COMPANY INC.]
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NDC	67751-170-01, 67751-170-02
Set ID	4139b5bf-2e49-40c3-9f4a-d8e15c044ead
Category	HUMAN OTC DRUG LABEL
Packager	Navajo Manufacturing Company Inc.
Generic Name
Product Class
Product Number
Application Number	PART336

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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 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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part336	09/23/2016

Labeler - Navajo Manufacturing Company Inc. (091917799)

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

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