Your browser does not support JavaScript! DIMENHYDRINATE TABLET [QUALITEST PHARMACEUTICALS]
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RxNorm Names

DIMENHYDRINATE tablet
[Qualitest Pharmaceuticals]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Active ingredient (in each tablet)

Dimenhydrinate 50 mg

Purpose

Antiemetic

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

  • nausea
  • vomiting
  • dizziness

Warnings

Do not use in 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

  • marked drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery

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

  • to prevent motion sickness, the first dose should be taken 1/2 to 1 hour before starting activity
  • to prevent or treat motion sickness, use the following dosing

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0603-3327
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMENHYDRINATE (DIPHENHYDRAMINE) DIMENHYDRINATE50 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize9mm
FlavorImprint Code 0111;V
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0603-3327-21100 in 1 BOTTLE, PLASTIC
2NDC:0603-3327-321000 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33603/01/2004
Labeler - Qualitest Pharmaceuticals (011103059)
Establishment
NameAddressID/FEIBusiness Operations
Vintage Pharmaceuticals-Huntsville825839835MANUFACTURE(0603-3327)

Revised: 12/2012
 
Qualitest Pharmaceuticals

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