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  5. Label Information: Meclizine

FDA Label for Meclizine

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH CAPLET)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. WHEN USING THIS PRODUCT
    6. IF PREGNANT OR BREAST-FEEDING,
    7. KEEP OUT OF REACH OF CHILDREN.
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. QUESTIONS?
    12. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Meclizine Product Label

The following document was submitted to the FDA by the labeler of this product Sda Laboratories, 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 Caplet)



Meclizine HCl 12.5mg


Purpose



Antiemetic


Uses



prevents and treats nausea, vomiting or dizziness associated with motion sickness


Warnings



Do not use for children under 12 years of age unless directed by a doctor.

Do not take unless directed by a doctor if you have

  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

    • Do not take if you are taking sedatives or tranquilizers, without first consulting your doctor.


When Using This Product



  • do not exceed recommended dosage
  • drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery

If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children.



In case of overdose, get medical help or contact a Poison Control Center right away.


Directions



  • doage should be taken 1 hour before travel starts 
    • Adults and children 12 years and over

    take 2 or 4 caplets once daily or as directed by doctor


Other Information



  • Tamper Evident: do not use if safety seal under cap is broken or missing
  • store at room temperature 20°-25°C (68°-77°F)

Inactive Ingredients



Croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid


Questions?



Adverse drug event call (800) 687-0176 (M - F, 8AM - 4PM EST).


Package Label.Principal Display Panel



NDC 66424-0386-10

MECLIZINE

Meclizine HCl 12.5mg

Anti-Emetic

• Motion Sickness • Nausea • Vomiting

1000 CAPLETS

SDA

LABORATORIES


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