DIMENHYDRINATE- dimenhydrinate tablet 
Carilion Materials Management

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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DIMENHYDRINATE TABLETS, USP 50 mg

Active ingredient (in each tablet)

Dimenhydrinate 50 mg

Purpose

Antiemetic

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

Warnings

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

Ask a doctor before use if you have

taking sedatives or tranquilizers Ask a doctor or pharmacist before use if you are

When using this product

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

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222).

Directions

adults and children 12 years and over 

1-2 tablets every 4-6 hours; not more than 8 tablets in 24 hours, or as directed by a doctor 

children 6 years to under 12 years 

1/2-1 tablet every 6-8 hours; not more than 3 tablets in 24 hours, or as directed by a doctor 

children 2 years to under 6 years 

1/4-1/2 tablet every 6-8 hours; not more than 1 1/2 tablets in 24 hours, or as directed by a doctor 

Other information

store at 15° to 30°C (59° to 86°F)

You may report serious side effects to: . 130 Vintage Drive, Huntsville, AL 35811

Inactive ingredients

colloidal silicone dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, stearic acid

Made in the for Qualitest Pharmaceuticals Huntsville, AL 35811 USA

Rev. 8/09 R4 8080234 0111

Dimenhydrinate

Label Image
DIMENHYDRINATE 
dimenhydrinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68151-1712(NDC:0603-3327)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIMENHYDRINATE50 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize9mm
FlavorImprint Code 0111;V
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68151-1712-21 in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33603/01/2004
Labeler - Carilion Materials Management (079239644)
Registrant - Carilion Materials Management (079239644)
Establishment
NameAddressID/FEIBusiness Operations
Carilion Materials Management079239644REPACK(68151-1712)

Revised: 12/2012
Document Id: 37dba1f7-1117-4a6e-afe5-e8684883ae2c
Set id: 637179aa-13ca-4116-a15f-c170b1eded4c
Version: 2
Effective Time: 20121221
 
Carilion Materials Management