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  5. Label Information: Meclizine Hcl

FDA Label for Meclizine Hcl

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH TABLET)
    2. PURPOSE
    3. USES:
    4. WARNINGS:
    5. DO NOT USE IN CHILDREN UNDER 12 YEARS OF AGE UNLESS DIRECTED BY A DOCTOR.
    6. WHEN USING PRODUCT
    7. KEEP OUT OF REACH OF CHILDREN.
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. PRINCIPAL DISPLAY PANEL - 25 MG CHEWABLE TABLET LABEL

Meclizine Hcl Product Label

The following document was submitted to the FDA by the labeler of this product Drug Ocean Llc. 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 Ingredients (In Each Tablet)



Meclizine HCl, USP 25 mg


Purpose



Antiemetic


Uses:



prevents and treats nausea, vomiting, or dizziness due to motion sickness.


Warnings:



Do not take this product, unless directed by a doctor, if you have

  • Glaucoma
  • A breathing problem such as emphysema or chronic bronchitis
  • Trouble urinating due to an enlarged prostate gland

Do Not Use In Children Under 12 Years Of Age Unless Directed By A Doctor.




When Using Product



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

Keep Out Of Reach Of Children.



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


Directions



  • dosage should be taken one hour before travel starts
    •  adults and children 12 years and over   take 2 or 4 tablets once daily or as directed by a doctor


Other Information



  • store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Inactive Ingredients



colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose


Principal Display Panel - 25 Mg Chewable Tablet Label



NDC 70985-010-01

Meclizine HCl Chewable
25 mg

100 Tablets

Distributed by:
Drug Ocean LLC,
221 River Street, Suite 9051,
Hoboken, NJ 07030

Manufactured by:
Unique Pharmaceutical Laboratories
(A Div. of J. B. Chemicals & Pharmaceuticals Ltd.)
Mumbai 400 030, India

ORG 05/21


* Please review the disclaimer below.