1. Home
  2. Labeler Index
  3. Medtech Products Inc.
  4. 63029-902
  5. Label Information: Dramamine Orange

FDA Label for Dramamine Orange

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USE
    5. WARNINGS
    6. DO NOT GIVE TO
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE TAKING
    9. WHEN USING THIS PRODUCT
    10. IF PREGNANT OR BREAST-FEEDING,
    11. KEEP OUT OF REACH OF CHILDREN.
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS?
    16. DRAMAMINE® CHEWABLE ORANGE MOTION SICKNESS RELIEF, 8 CT
    17. DRAMAMINE® CHEWABLE ORANGE MOTION SICKNESS RELIEF, 4 CT

Dramamine Orange Product Label

The following document was submitted to the FDA by the labeler of this product Medtech Products 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.

Other



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



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

Ask A Doctor Or Pharmacist Before Use If You Are Taking



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 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 tables every 4-6 hours
    • do not take more than 8 tablets in 24 hours, or as directed by a doctor
    Children 6 to
    under 12 years
    • give ½ to 1 tablet every 6-8 hours
    • do not give more than 3 tablets in 24 hours, or as directed by a doctor
    Children 2 to
    under 6 years
    • give ½ tablet every 6-8 hours
    • do not give more than 1 ½ 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)
  • see side panel for lot number and expiration date
  • Tamper Evident: Do not use if pouch is torn or open.

  • do not use if carton is opened or if blister is broken or torn


Inactive Ingredients



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


Questions?



Call 1-800-382-7219


* Please review the disclaimer below.