Curist Allergy Relief Tablet, Coated
FDA Label NDC 72559-003

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Little Pharma, Inc. for the product Curist Allergy Relief (NDC 72559-003). 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 other safety information, other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other Safety Information

Important: Read the directions and warnings before use. Keep the carton, it contains important information.

Do not use if imprinted foil inner seal on bottle is broken or missing.

Otc - Active Ingredient

Active ingredient (in each tablet)

Cetirizine HCl 10 mg

Otc - Purpose

Purpose

Antihistamine

Indications & Usage

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

Otc - Do Not Use

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.

Otc - Ask Doctor

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

Otc - When Using

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

Otc - Stop Use

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding:

  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use

Otc - 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 (1-800-222-1222) right away.

Dosage & Administration

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

Storage And Handling

Other information

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

Inactive Ingredient

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

Package Label.Principal Display Panel

curist

Allergy Relief

Cetirizine Hydrochloride Tablets, USP 10 mg

Antihistamine

24 Hour Relief of Runny Nose; Sneezing; Itchy, Watery Eyes; Itchy Nose or Throat

30 Tablets

* Please review the disclaimer below.