Meclizine Hcl
FDA Label NDC 13811-646

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Trigen Laboratories, Inc. for the product Meclizine Hcl (NDC 13811-646). 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 ingredients (in each caplet), purpose, uses:, warning: ask a doctor before use if you have, keep out of reach of children, when using product, 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 Ingredients (In Each Caplet)

Meclizine HCl 12.5 mg

Purpose

Antiemetic

Uses:

prevents and treats nausea, vomiting, or dizziness due to motion sickness.• For other uses, consult your doctor.

Warning: 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.

Keep Out Of Reach Of Children

When Using Product

• You may get drowsy • Avoid alcoholic drinks • Alcohol, sedatives and tranquilizers may increase drowsiness • Be careful when driving a motor vehicle or operating machinery

Keep Out Of Reach Of Children.

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

Directions

• Adults & 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

Microcrystalline cellulose, magnesium stearate, sodium starch glycolate, crospovidone, talc, and lactose.

Principal Display Panel - 12.5 Mg Caplet Label

NDC 13811-646-10

Meclizine HCl
12.5 mg

100 CAPLETS

TRIGEN
LABORATORIES

Manufactured for:
TRIGEN Laboratories, Inc., Sayreville, NJ 08872
www.trigenlab.com
Rev. 08/13

Principal Display Panel (12.5 mg)

Principal Display Panel (12.5 mg)

* Please review the disclaimer below.