Dimenhydrinate by Major Pharmaceuticals DIMENHYDRINATE tablet

Dimenhydrinate by

Drug Labeling and Warnings

Dimenhydrinate by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)

Dimenhydrinate 50 mg

PURPOSE

Purpose

Antiemetic

Uses

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

WARNINGS

Do not give to 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

■ 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

■ 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 (1-800-222-1222) right away.

Directions

■ to prevent motion sickness, the rst dose should be taken one-half to one hour before starting activity

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

■ 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: 1/2 tablet every 6-8 hours; not to exceed 1 1/2 tablets in 24 hours, or as directed by a doctor

Other information

■ each tablet contains: calcium 29 mg

■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

■ protect from moisture

■ see end -ap for expiration date and lot number

■ TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN

INACTIVE INGREDIENT

croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose

Questions or comments?

1-800-616-2471

SPL UNCLASSIFIED SECTION

KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

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

Distributed by: MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152 USA

PRINCIPAL DISPLAY PANEL

MAJOR ®

NDC: 0904-6772-12

Compare to the Active Ingredient in DRAMAMINE ® Original Formula*

Driminate TM

Dimenhydrinate USP, Antiemetic

For Nausea, Dizziness and Vomiting from Motion Sickness

12 Tablets 50mg Each

Use as Directed

INGREDIENTS AND APPEARANCE

DIMENHYDRINATE 
dimenhydrinate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-6772
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMENHYDRINATE (UNII: JB937PER5C) (CHLORTHEOPHYLLINE - UNII:GE2UA340FM)	DIMENHYDRINATE	50 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	9mm
Flavor		Imprint Code	1006;1006
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-6772-12	1 in 1 CARTON	02/14/2019
1		12 in 1 BLISTER PACK; 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	02/14/2019

Labeler - Major Pharmaceuticals (191427277)