FDA Label for Dramamine

View Indications, Usage & Precautions

Dramamine Product Label

The following document was submitted to the FDA by the labeler of this product Select Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

Dist By:
Medtech Products, Inc. Tarrytown, NY 10591

Product Repackaged and Distributed
with permission of manufacturer by:
Select Corporation Carrollton, TX 75007


Active Ingredient (In Each Tablet)



Dimenhydrinate 50 mg


Purpose



Antiemetic


Use



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

  • nausea
  • vomiting
  • dizziness

Warnings



Do not give to 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
  • trouble urinating due to an enlarged prostate gland

Otc - Ask Doctor/Pharmacist



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


When Using This Product



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

Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.

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


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, see below:
  • adults and children 12 years and over
    • take 1 to 2 chewable tablets every 4-6 hours
    • do not take more than 8 chewable tablets in 24 hours, or as directed by a doctor
    children 6 to under 12 years
    • give 1/2 to 1 chewable tablet every 6-8 hours
    • do not give more than 3 chewable tablets in 24 hours, or as directed by a doctor
    children 2 to under 6 years
    • give 1/2 chewable tablet every 6-8 hours
    • do not give more than 1½ chewable tablets in 24 hours, or as directed by a doctor

Other Information



  • Phenylketonurics: contains phenylaline 0.84 mg per tablet
  • store at room tempurature 20°- 25°C (68°-77°F)
  • do not use if pouch is opened
  • see bottom of this panel for lot number and expiration date

Inactive Ingredients



anhydrous citric acid, aspartame, FD&C yellow #6 aluminum lake, flavors, magnesium stearate, maltodextrin, methacrylic acid copolymer, modified starch, sorbitol


Questions Or Comments?



call 1-800-382-7219


Principal Display Panel - 50 Mg Tablet Packet Carton



#1
Pharmacist
Recommended
BRAND

DIMENHYDRINATE
TABLETS / ANTIEMETIC

Dramamine®

motion sickness

CHEWABLE

Dual Action:

Prevents & Relieves Nausea,
Dizziness and Vomiting

TO OPEN
PUSH IN TAB AND PULL OUT

25 Packets of 2 Orange Flavor Tablets
(50 mg each)


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