Curist Allergy Relief (cetirizine Hcl) Tablets

Curist Allergy Relief (cetirizine Hcl) Tablets
SPL v5
SPL
SPL Set ID 8c429732-5cf3-f41b-e053-2995a90a302a
Route
ORAL
Published
Effective Date 2019-06-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetirizine (10 mg)
Inactive Ingredients
Lactose Monohydrate Croscarmellose Sodium Silicon Dioxide Magnesium Stearate Cellulose, Microcrystalline Hypromellose, Unspecified Titanium Dioxide Polyethylene Glycol

Identifiers & Packaging

Pill Appearance
Imprint: G;4 Shape: rectangle Color: white Size: 9 mm Score: 2
Marketing Status
ANDA Active Since 2019-06-26
Description

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.

Medication Information

Warnings and Precautions

Warnings

Indications and 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
Dosage and Administration

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

Description

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.

Section 42229-5

Drug Facts

Section 44425-7

Other information

  • store between 20° to 25°C (68° to 77°F)
  • contains no ingredient from a gluten-containing grain (Wheat, barley, rye)
Section 50565-1

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.

Section 50566-9

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

Section 50567-7

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
Section 50568-5

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

Section 50569-3

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

Section 50570-1

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.

Section 51727-6

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

Section 51945-4

curist

Allergy Relief

Cetirizine Hydrochloride Tablets, USP 10 mg

Antihistamine

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

365 Tablets

Section 53413-1

Questions? Call 1-877-770-3183

Weekdays 9:00 AM to 4:30 PM EST

Section 53414-9

If pregnant or breast-feeding:

  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use
Section 55105-1

Purpose

Antihistamine

Section 55106-9

Active ingredient (in each tablet)

Cetirizine HCl 10 mg

Section 60561-8

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.

Structured Label Content

Indications and Usage (34067-9)

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
Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information

  • store between 20° to 25°C (68° to 77°F)
  • contains no ingredient from a gluten-containing grain (Wheat, barley, rye)
Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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
Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

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.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

curist

Allergy Relief

Cetirizine Hydrochloride Tablets, USP 10 mg

Antihistamine

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

365 Tablets

Section 53413-1 (53413-1)

Questions? Call 1-877-770-3183

Weekdays 9:00 AM to 4:30 PM EST

Section 53414-9 (53414-9)

If pregnant or breast-feeding:

  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use
Section 55105-1 (55105-1)

Purpose

Antihistamine

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Cetirizine HCl 10 mg

Section 60561-8 (60561-8)

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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:28.361959 · Updated: 2026-03-14T23:05:14.204136