DIMENHYDRINATE- dimenhydrinate tablet 
Qualitest 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.

----------

DIMENHYDRINATE TABLETS, USP
50 mg

Active ingredient (in each tablet)

Dimenhydrinate 50 mg

Purpose

Antiemetic

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

Warnings

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

Ask a doctor before use if you have

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

When using this product

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 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 USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811

Rev. 8/09 R4
8080234 0111

PRINCIPAL DISPLAY PANEL

This is an image of the label for Dimenhydrinate Tablets, USP 50 mg 1000 count.

 

DIMENHYDRINATE 
dimenhydrinate tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0603-3327
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)  
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
Color WHITE Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code 0111;V
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0603-3327-21 100 in 1 BOTTLE, PLASTIC
2 NDC:0603-3327-32 1000 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part336 03/01/2004
Labeler - Qualitest Pharmaceuticals (011103059)
Establishment
Name Address ID/FEI Business Operations
Vintage Pharmaceuticals-Huntsville 825839835 MANUFACTURE(0603-3327)

Revised: 12/2012
Document Id: ec450ba6-f03d-4820-8dbe-0a8e0227ce26
Set id: b4e1e0e9-a7cf-4c10-9e1b-0f4110be0767
Version: 2
Effective Time: 20121221
 
Qualitest Pharmaceuticals