Meclizine 25
FDA Label NDC 57963-101

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Generic Pharmaceutical Company for the product Meclizine 25 (NDC 57963-101). 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 other, active ingredients (in each immediate-release tablet), purpose, indications and usage, warnings, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Manufactured for
The Generic Pharmaceutical Company, Inc.
Leeds, AL 35094

Active Ingredients (In Each Immediate-Release Tablet)

Meclizine 25 mg

Purpose

Antiemetic

Indications And Usage

  • For prevention and treatment of these symptoms associated with motion sickness:
    • nausea
    • vomiting
    • dizziness

Warnings

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

Ask A Doctor Before Use If You Have

  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When Using This Product

  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding,

  • ask health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

In case of accidental overdose, seek medical help or contact a Poison Control Center immediately. 1-800-222-1222

Directions

Do not exceed recommended dosage.

To prevent motion sickness; take the first dose one hour before starting activity.

Adults and children 12 years of age and over:1 to 2 tablets once daily, or as directed by a doctor.

Inactive Ingredients

Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate

Questions And Comments?

Call 1-205-313-8298

Principal Display Panel - 25 Mg Tablet Bottle Label

NDC 57963-101-01
100 Tablets

Meclizine 25
Antiemetic

Each immediate-release tablet contains:
Meclizine HCl
25 mg

Store at 59°-86°F (15°-30°C)
[see USP Controlled Room Temperature].
Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.

Manufactured for
The Generic Pharmaceutical Company, Inc.
Leeds, AL 35094

Principal Display Panel (25 mg Tablet Bottle Label)

Principal Display Panel (25 mg Tablet Bottle Label)

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