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  5. Label Information: Dramamine Chewable Dimenhydrinate

FDA Label for Dramamine Chewable Dimenhydrinate

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENT (IN EACH TABLET)
    3. PURPOSE
    4. USE
    5. WARNINGS
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE
    8. WHEN USING THIS PRODUCT
    9. IF PREGNANT OR BREAST-FEEDING,
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS?
    15. PACKAGE LABELING:

Dramamine Chewable Dimenhydrinate Product Label

The following document was submitted to the FDA by the labeler of this product Jc World Bell Wholesale Co., Inc.. 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.

Drug Facts




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 givetochildren under 12 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

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

If Pregnant Or Breast-Feeding,



ask a doctor before use.


Keep Out Of Reach Of Children.



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


Directions



  • to prevent motion sickness, the first dose should be taken ½ 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 ½ 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 ½ chewable tablet every 6-8 hours
    • do not give more than 1 ½ chewable tablets
      in 24 hours, or as directed by a doctor


Other Information



  • Phenylketonurics: contains phenylalanine 0.84 mg per tablet
  • store at room temperature 20-25°C (68-77°F)
  • see side panel for lot number and expiration date

Inactive Ingredients



anhydrous-citric-acid, aspartame, FD&C yellow no. 6 aluminum lake, flavors, magnesium stearate, maltodextrin, methacrylic acid copolymer, modified starch, sorbitol


Questions?



1-800-382-7219 Dramamine.com


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