Meclizine Hcl
FDA Label NDC 70985-010

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Drug Ocean Llc for the product Meclizine Hcl (NDC 70985-010). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (in each tablet), purpose, uses:, warnings:, do not use in children under 12 years of age unless directed by a doctor., when using product, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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