Dimenhydrinate by Carilion Materials Management DIMENHYDRINATE tablet

Dimenhydrinate by

Drug Labeling and Warnings

Dimenhydrinate by is a Otc medication manufactured, distributed, or labeled by Carilion Materials Management. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Dimenhydrinate 50 mg

Purpose

Antiemetic

INDICATIONS & USAGE

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

• nausea
• vomiting
• dizziness

Warnings

DO NOT USE

in children under 2 years of age unless directed by a doctor Do not use

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 DOCTOR/PHARMACIST

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

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

PREGNANCY OR BREAST FEEDING

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

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

SPL UNCLASSIFIED SECTION

Made in the for Qualitest Pharmaceuticals Huntsville, AL 35811 USA

Rev. 8/09 R4 8080234 0111

Dimenhydrinate

INGREDIENTS AND APPEARANCE

DIMENHYDRINATE 
dimenhydrinate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68151-1712(NDC: 0603-3327)
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68151-1712-2	1 in 1 PACKAGE

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

Labeler - Carilion Materials Management (079239644)

Registrant - Carilion Materials Management (079239644)

Establishment
Name	Address	ID/FEI	Business Operations
Carilion Materials Management		079239644	REPACK(68151-1712)