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  5. Label Information: Dramamine Original Formula

FDA Label for Dramamine Original Formula

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    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 YOU ARE
    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. PRINCIPAL DISPLAY PANEL

Dramamine Original Formula 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.

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 dizziness
  • 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



  • store at room temperature 68-77°F (20-25°C)
  • do not use if carton is open or if blister unit is broken or torn
  • see side panel for lot number and expiration date

Inactive Ingredients



anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose


Questions Or Comments?



Call 1-800-382-7219






Principal Display Panel



Dimenhydrinate Tablets/Antiemetic
ORIGINAL FORMULA Dramamine®
MOTION SICKNESS RELIEF
DUAL ACTION
1. TREATS SYMPTOMS ON THE SPOT
2. PREVENS NAUSEA, DIZZINESS & VOMITING
36 Tablets (50 mg EACH)

PRINCIPAL DISPLAY PANELDimenhydrinate Tablets/AntiemeticORIGINAL FORMULA Dramamine36 Tablets (50 mg EACH) - dramamine original formula 01

PRINCIPAL DISPLAY PANELDimenhydrinate Tablets/AntiemeticORIGINAL FORMULA Dramamine36 Tablets (50 mg EACH) - dramamine original formula 01


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