Crcle Cetirizine Hydrochloride Tablet
FDA Label NDC 57483-250

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Innovus Pharmaceuticals, Inc. for the product Crcle Cetirizine Hydrochloride (NDC 57483-250). 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, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, 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 HCl 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

Warnings

Do Not Use

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

Ask A Doctor Before Use If You Have

liver or kidney disease. Your doctor should determine if you need a different dose.

Ask A Doctor Or Pharmacist Before Use If You Are

taking tranquilizers or sedatives.

When Using This Product

  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop Use And Ask A Doctor If

an allergic reaction to this product occurs. Seek medical help right away.

If Pregnant Or Breast-Feeding:

  • if breast-feeding: not recommended
  • if pregnant: 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. (1-800-222-1222)

Directions

adults and children 6 years and over
- 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 65 years and over
- ask a doctor
children under 6 years of age
- ask a doctor
consumers with liver or kidney disease
- ask a doctor

Other Information

  • store between 20° to 25°C (68° to 77°F) 
  • contains no ingredient made from a gluten-containing grain (Wheat, barley or rye)

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

Questions?

call 1-877-770-3183: Weekdays 8:00 AM EST to 5:00 PM PST.

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