Meclizine Hcl
FDA Label NDC 10544-249

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Blenheim Pharmacal, Inc. for the product Meclizine Hcl (NDC 10544-249). 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 ingredient, purpose, uses, warnings, directions, other information, inactive ingredients, questions or comments, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

(in each caplet)

Meclizine HCl 12.5 mg USP

Purpose

Antiemetic

Uses

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

Warnings

Ask a doctor before use if you have

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • 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

    • you may get drowsy
    • avoid alcoholic drinks
    • alcohol, sedatives & tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating a 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

  • adults and children 12 years and over: 2-4 caplets once daily
  • children under 12 years: ask a doctor

Other Information

  • each caplet contains: calcium 51 mg
  • store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients

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

Questions Or Comments

Call 1-800-645-2158, 9 am – 5 pm ET, Monday - Friday

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR BLISTER UNIT IS BROKEN OR DAMAGED

Rugby® Duluth, Georgia 30097

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