Medique Medi-meclizine
FDA Label NDC 50090-4493

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by A-s Medication Solutions for the product Medique Medi-meclizine (NDC 50090-4493). 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 ingredient (in each tablet), purpose, uses, do not use, ask a doctor before use if you have, if you are, 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

Adults and children: (12 years and older) 1 to 2 tablets once daily or as directed by a doctor. Do not exceed 2 tablets in 24 hours.

Children under 12 years: Do not give to children under 12 years of age.

Active Ingredient (In Each Tablet)

Meclizine Hydrochloride 25 mg

Purpose

Antiemetic

Uses

For the prevention and treatment of the nausea, vomiting, or dizziness associated with motion sickness.

Do Not Use

  • for children under 12 years of age unless directed by a doctor
  • for frequent or prolonged use except under the advice of a doctor

Ask A Doctor Before Use If You Have

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

If You Are

  • taking sedatives or tranquilizers

When Using This Product

  • drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase the drowsiness effect
  • avoid alcoholic beverages while taking this product
  • use caution when driving a motor vehicle or operating machinery

    • Do not exceed recommended dosage.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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

Directions

  • do not use more than directed
  • to prevent motion sickness, take the first dose one hour before starting activity

Other Information

  • store at room temperature 59- 86° F (15-30°C)
  • tamper-evident sealed packets
  • do not use any opened or torn packets

Inactive Ingredients

anhydrous lactose, colloidal silicon dioxide, corn starch, D&C yellow # 10, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions Or Comments?

1-800-634-7680

How Supplied

Product: 50090-4493

NDC: 50090-4493-0 2 TABLET in a PACKET / 500 in a BOX

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