Meclizine Hcl Tablet, Chewable
FDA Label NDC 71610-528

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aphena Pharma Solutions - Tennessee, Llc for the product Meclizine Hcl (NDC 71610-528). 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, keep out of reach of children., other information, 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

Meclizine Hydrochloride 25 mg

Purpose

Antiemetic

Uses

For the prevention and treatment of nausea, vomiting or dizziness associated with motion sickness. For other uses consult your doctor

Warnings

Ask a doctor before use if you have

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an elarged 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 and tranquilizers may increse drowsiness
    • be careful when driving a moor vehicle or operating machinery

Directions

take dose one hour before travel starts
tablets can be chewed or swallowed whole with water

adults & children 12 years and over:

  • take 1-2 tablets once daily

    • children under 12 years:

    • ask a doctor

Keep Out Of Reach Of Children.

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

Other Information

Phenylketonurics:
each tablet contains:
phenylalanine 0.28 mg
store at room temparature 15 - 30 °C

Questions Or Comments

Call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive Ingredients

Aspartame, compressible sugar, croscarmellose sodium, dextrose, FD&C red 40 (al-lake), magnesium stearate, microcrystalline cellulose, raspberry flavor

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count25 mg
3071610-0528-30
9071610-0528-60

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:

Aphena Pharma Solutions (TN)

Aphena Pharma Solutions (TN)


Cookeville, TN 38506

20210415JH

Principal Display Panel - 25 Mg

NDC 71610-528 - Meclizine HCl 25 mg Chewable Tablets

Bottle Label 25 mg (71610 0528 30)

Bottle Label 25 mg (71610 0528 30)

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