DIMENHYDRINATE - dimenhydrinate tablet, film coated 
Time Cap Labs, Inc

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.

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EACH TABLET CONTAINS DIMENHYDRINATE 50 MG


COLLOIDAL SILICON DIOXIDE, CROSCARMELLOSE SODIUM,HYPROMELLOSE, AHNYDROUS LACTOSE, MAGNESIUM STEARATE, CELLULOSE, MICROCRYSTALLINE, MINEROL

Antiemetic

Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away

irections:

To prevent motion sickness, the first 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 to 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 to 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 to 8 hours,not to exceed 1 1/2 tablets in 24 hours, or as directed by a doctor

Warnings

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

 

Use

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

nauseavomitingdizziness

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.  Be careful when driving a motor vehicle or operating machinery.

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

blister

DIMENHYDRINATE  
dimenhydrinate tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49483-352
Route of Administration ORAL DEA Schedule     
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)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code TCL;352
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49483-352-36 36 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part336 01/28/2011
Labeler - Time Cap Labs, Inc (037052099)
Establishment
Name Address ID/FEI Business Operations
Time Cap Labs, Inc. 037052099 manufacture(49483-352)

Revised: 3/2013
Document Id: 1a1fa4eb-5672-4f61-8e95-2c5f00d08f69
Set id: a45fd02d-f558-4116-ad97-0583f92dc8e9
Version: 1
Effective Time: 20130327
 
Time Cap Labs, Inc