DIMENHYDRINATE- 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.

----------

1006-Major

Drug Facts

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

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

croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose

Questions or comments?

1-800-616-2471

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

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

1006-major label

DIMENHYDRINATE 
dimenhydrinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6772
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMENHYDRINATE (UNII: JB937PER5C) (CHLORTHEOPHYLLINE - UNII:GE2UA340FM) DIMENHYDRINATE50 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize9mm
FlavorImprint Code 1006;1006
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-6772-121 in 1 CARTON02/14/2019
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33602/14/2019
Labeler - Major Pharmaceuticals (191427277)

Revised: 11/2020
Document Id: b4043aed-f29f-c266-e053-2995a90a1c58
Set id: 78d22836-a442-7c0c-e053-2991aa0a62f3
Version: 2
Effective Time: 20201113
 
Major Pharmaceuticals