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Driminate by Major Pharmaceuticals

Dosage form: tablet
Ingredients: DIMENHYDRINATE 50mg
Labeler: Major Pharmaceuticals
NDC Code: 0904-2051

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
  • 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
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • marked drowsiness may occur
  • use caution when driving a motor vehicle or operating machinery
  • avoid alcoholic beverages

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 first dose should be taken one-half to one hour before starting activity
adults and
children
12 years
and over
  1 to 2 tablets every 4-6
 hours; do not exceed 8
 tablets in 24 hours, or as
 directed by a doctor
children 6
to under
12 years
 1/2 to 1 tablet every 6-8
 hours; do not exceed 3
 tablets in 24 hours, or as
 directed by a doctor 
children 2
to under
6 years
 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protect from moisture
  • see end flap for expiration date and lot number

Inactive ingredients

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

Questions or comments?

(800) 616-2471

Principal Display Panel

MAJOR®

NDC 0904-2051-12

Compare to the Active Ingredient in DRAMAMINE® Original Formula*

Driminate™

Dimenhydrinate USP, Antiemetic

For Nausea, Dizziness and Vomiting from Motion Sickness

12 Tablets
50 mg EACH
Use as Directed

TAMPER EVIDENT: DO NOT USE IF PACKAGE 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® Original Formula.
50844    REV1115K19802

Distributed by MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152 USA
Re-order No.  700466
M-17    Rev. 09/16

Major 44-198

DRIMINATE 
dimenhydrinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-2051
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMENHYDRINATE (DIPHENHYDRAMINE) DIMENHYDRINATE50 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
STEARIC ACID 
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize9mm
FlavorImprint Code44;198
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-2051-121 BLISTER PACK in 1 CARTON
112 TABLET in 1 BLISTER PACK
2NDC:0904-2051-591 BOTTLE in 1 CARTON
2100 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33612/01/1992
Labeler - Major Pharmaceuticals (191427277)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(0904-2051)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(0904-2051)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(0904-2051)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(0904-2051)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(0904-2051)

 
Major Pharmaceuticals

Medically reviewed on Nov 28, 2017

See Also

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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