Aptrizine
FDA Label NDC 46084-012

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 P J Laboratories Limited for the product Aptrizine (NDC 46084-012). 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, keep out of reach of children, indications and usage, warning, dosage and administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Purpose

Antihistamine

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.

Indications And Usage

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies, runny nose, sneezing, itchy, watery eyes, itching of the nose or throat.

Warning

If you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Dosage And Administration

Adults and children 6years andover One 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. Adults 65years and over: ask a doctor. Children under 4-6 years of age: ask a doctor Children under 4 years of age: ask a doctorConsumers with liver or kidney disease: ask a doctor

Inactive Ingredient

LACTOSE MONOHYDRATE

STARCH, CORN

GELATIN
METHYLPARABEN
TITANIUM DIOXIDE
MAGNESIUM STEARATE
TALC
SODIUM STARCH GLYCOLATE TYPE A POTATO

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