Meclinzine Hydorchloride
FDA Label NDC 59961-125

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bellegrove Medical Supply, Inc. for the product Meclinzine Hydorchloride (NDC 59961-125). 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 warnings, dosage and administaation, indication and usage, otc-keep out of reach of children, purpose, active ingredients, inactive ingredients, package label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Warnings

Do not use
• for children under 12 years of age unless unless directed by a physician
• for frequent or prolonged use except under the advice of a physician

Ask a doctor before use if you have

breathing problems such as emphysema, asthma or pulmonary disease
glaucoma

if you are 

  • taking sedatives or tranquilizers

    • When using this product

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

    Do not exceed recommended dosage

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

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

    Other information

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

Dosage And Administaation

Directions

do not use more than directed
to provent motion sickness, take the first dose one hour before starting activity
Adults and children (12 years and older)

1 to 2 tablets once daily or as directed by a Physician

Do not exceed 2 tablets in 24 hours

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

Indication And Usage

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

Otc-Keep Out Of Reach Of Children

Do not use
• for children under 12 years of age unless unless directed by a physician
Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away

Purpose

When using this product

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

Active Ingredients

anhydrous lactose

Inactive Ingredients

Anhydrous Lactose, Colloidal Silicon Dioxide, Crospovidone, Dextrose, FD&C red #40 aluminum lake, magnesium stearate, Microcrystalline Cellulose, Modified Corn Starch, Propylene Glycol, Raspberry Flavor, Silicon Dioxide, Sodium Saccharin, Stearic Acid, Talc and Vanilla Flavor.

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