Cetirizine Hydrochloride Tablet, Film Coated
FDA Label NDC 69452-465

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bionpharma Inc. for the product Cetirizine Hydrochloride (NDC 69452-465). 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, directions, other information, inactive ingredients, questions or comments?, package label.principal display panel, 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)

Cetirizine Hydrochloride USP, 10 mg

Purpose

Antihistamine

Uses

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

Directions

adults and children 6 years and overone 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 65 years and overask a doctor
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other Information

store between 20° to 25°C (68° to 77°F).

Inactive Ingredients

corn starch, lactose monohydrate, povidone, magnesium stearate and opadry white. The components of opadry white are: hydroxypropyl methylcellulose, polyethylene glycol 400, titanium dioxide

Questions Or Comments?

call toll-free 1-888-235-2466

Package Label.Principal Display Panel

'compare to the active ingredient in Zyrtec®​ Allergy

NDC 69452-465-81

a+healthTM

original prescription strength

allergy relief

cetirizine HCl tablets USP, 10 mg

antihistamine

6 years and older

indoor & outdoor allergies

24 hour relief of:

  • sneezing
  • runny nose
  • itchy, watery eyes
  • itchy, throat or nose

    • 400 tablets

    400s Count Label (Label)

    400s Count Label (Label)

* Please review the disclaimer below.