DRIMINATE- dimenhydrinate tablet
Major 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.

----------

Major 44-198

Active ingredient (in each tablet)

Dimenhydrinate 50 mg

Purpose

Antiemetic

Uses

for the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness

Warnings

Do not use

for children under 2 years of age unless directed by a doctor

Ask a doctor before use if you have

glaucoma
a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to an enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

do not exceed recommended dosage
marked drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
use caution 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.

Directions

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

Other information

store at controlled room temperature 15º - 30ºC (59º - 86ºF)
protect from moisture
for better identification keep tablets in carton until used

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silica gel, stearic acid

Questions or comments?

call 1-800-426-9391

Principal Display Panel

NDC 0904-2051-12
*Compare to the Active Ingredient in Dramamine® Tablets

Driminate™

For Nausea, Dizziness and Vomiting from Motion Sickness

Dimenhydrinate USP, Antiemetic

100 Tablets
50 mg EACH
Use as Directed

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by Prestige Brands, Inc., owner of the registered trademark Dramamine® Tablets.
50844 REV0512J19812

Distributed by Major Pharmaceuticals
31778 Enterprise Drive
Livonia, MI 48150 USA M-17
1-734-743-6000
Reorder No. 700621

Major 44-198

DRIMINATE
dimenhydrinate tablet

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:0904-2051
Route of Administration	ORAL	DEA Schedule

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

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STEARIC ACID

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	ROUND	Size	11mm
Flavor		Imprint Code	44;198
Contains

#	Item Code	Package Description
Packaging
1	NDC:0904-2051-12	1 in 1 CARTON
1		12 in 1 BLISTER PACK
2	NDC:0904-2051-59	1 in 1 CARTON
2		100 in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part336	12/01/1992

Labeler - Major Pharmaceuticals (191427277)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	MANUFACTURE(0904-2051)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(0904-2051)

Revised: 1/2014

Document Id: f98078ef-cf83-495c-b265-c4ef5d5a34f8

Set id: d2967f78-41ee-4c30-8b47-0757df9f3d91

Version: 4

Effective Time: 20140130

Major Pharmaceuticals