DIMENHYDRINATE - dimenhydrinate tablet
Qualitest Pharmaceuticals

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredient (in each tablet)

Dimenhydrinate 50 mg

Purpose

Antiemetic

Uses for prevention and treatment of these symptoms associated with motion sickness:

nausea
vomiting
dizziness

Warnings

Do not use in 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
difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

marked drowsiness may occur
alcohol, sedatives and tranquilizers may increase drowsiness
avoid alcoholic drinks
be careful when driving a motor vehicle or operating machinery

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222).

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, use the following dosing

adults and children 12 years and over	1-2 tablets every 4-6 hours; not more than 8 tablets in 24 hours, or as directed by a doctor
children 6 years to under 12 years	1/2-1 tablet every 6-8 hours; not more than 3 tablets in 24 hours, or as directed by a doctor
children 2 years to under 6 years	1/4-1/2 tablet every 6-8 hours; not more than 1 1/2 tablets in 24 hours, or as directed by a doctor

Other information

store at 15° to 30°C (59° to 86°F)

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive ingredients

colloidal silicone dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, stearic acid

Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811

Rev. 8/09 R4
8080234 0111

PRINCIPAL DISPLAY PANEL

This is an image of the label for Dimenhydrinate Tablets, USP 50 mg 1000 count.

DIMENHYDRINATE
dimenhydrinate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0603-3327
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMENHYDRINATE (DIMENHYDRINATE)	DIMENHYDRINATE	50 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	ROUND	Size	9mm
Flavor		Imprint Code	0111;V
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:0603-3327-21	100 TABLET (100 TABLET) in 1 BOTTLE, PLASTIC	None
2	NDC:0603-3327-32	1000 TABLET (1000 TABLET) in 1 BOTTLE, PLASTIC	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part336	03/01/2004

Labeler - Qualitest Pharmaceuticals (011103059)

Establishment
Name	Address	ID/FEI	Operations
Vintage Pharmaceuticals-Huntsville		825839835	MANUFACTURE

Revised: 01/2012 Qualitest Pharmaceuticals