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  5. Label Information: Dramamine

FDA Label for Dramamine

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TABLET)
    2. PURPOSE
    3. USE
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. ASK A DOCTOR OR PHARMACIST BEFORE USE IF
    7. WHEN USING THIS PRODUCT
    8. IF PREGNANT OR BREAST-FEEDING,
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. PACKAGE LABELING:

Dramamine Product Label

The following document was submitted to the FDA by the labeler of this product Navajo Manufacturing Company 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.

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


Do Not Use



for 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


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 accidental 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 1/2 to 1 hour before starting activity
to prevent or treat motion sickness:

 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 1-1/2 chewable tablets in 24 hours, or as directed by a doctor


Other Information



• Phenylketonurics: contains phenylalanine 0.75 mg per tablet
• store at room temperature 20°-25°C (68°- 77°F)
• do not use if pouch is opened
• see pouch 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


Package Labeling:



Dramamine - Dramamine

Dramamine - Dramamine


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