Meclizine Tablet, Chewable
FDA Label NDC 16103-387

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pharbest Pharmaceuticals, Inc. for the product Meclizine (NDC 16103-387). 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 (in each tablet), purpose, uses, warnings, when using this product, if pregnant or breast-feeding,, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Tablet)

Meclizine HCl 25mg

Purpose

Antiemetic

Uses

prevents and treats nausea, vomiting or dizziness associated with motion sickness

Warnings

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

Do not take unless directed by a doctor if you have

  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

    • Do not take if you are taking sedatives or tranquilizers, without first consulting your doctor.

When Using This Product

  • do not exceed recommended dosage
  • drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating 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

  • doage should be taken 1 hour before travel starts  
    • Adults and children 12 years and over

    take 1 or 2 tablets once daily or as directed by doctor

Other Information

  • Tamper Evident: do not use if safety seal under cap is broken or missing
  • store at room temperature 20°-25°C (68°-77°F)

Inactive Ingredients

Croscarmellose sodium, dextrose, FD&C Red#40, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium saccharine, stearic acid

Questions?

Adverse drug event call (866) 562-2756 (M - F, 8AM - 4PM EST).

Package Label.Principal Display Panel

PHARBEST

NDC 16103-0387-11

Manufactured in the USA

Chewable, Once-A-Day Protection

MECLIZINE

CHEWABLE

Raspberry Flavor

*Compare to the active ingredient in Bonine®

Meclizine HCl 25mg

Anti-Emetic

• Motion Sickness • Nausea • Vomiting

1000 TABLETS

* Please review the disclaimer below.