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DIMENHYDRINATE by Time Cap Labs, Inc

Dosage form: tablet, film coated
Ingredients: DIMENHYDRINATE 50mg
Labeler: Time Cap Labs, Inc
NDC Code: 49483-352

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.

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. 

DIMENHYDRINATE  
dimenhydrinate tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-352
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMENHYDRINATE (DIPHENHYDRAMINE) DIMENHYDRINATE50 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
ANHYDROUS LACTOSE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
MINERAL OIL 
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize8mm
FlavorImprint CodeTCL;352
Contains    
Packaging
#Item CodePackage Description
1NDC:49483-352-3636 TABLET, FILM COATED (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33601/28/2011
Labeler - Time Cap Labs, Inc (037052099)
Establishment
NameAddressID/FEIOperations
Time Cap Labs, Inc.037052099manufacture(49483-352)

Revised: 03/2013
 
Time Cap Labs, Inc

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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