Cetirizine Hydrochloride Oral Solution 1 Mg/ml

Cetirizine Hydrochloride Oral Solution 1 Mg/ml
SPL v2
SPL
SPL Set ID 9c0549cf-4c93-45d9-9eac-3948fa45554e
Route
ORAL
Published
Effective Date 2026-01-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetirizine (1 mg)
Inactive Ingredients
Methylparaben Propylparaben Glycerin Propylene Glycol Sodium Acetate Grape Acetic Acid Sucrose Water

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
ANDA Active Since 2025-01-01

Description

Drug Facts

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Drug Facts

Uses

temporarily relieves these symptoms due to hay fever or upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
Section 42229-5

Drug Facts

Section 50565-1

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)

Section 50566-9

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

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.

Directions
  • use only with enclosed dosing cup 
  • adults and children 6 years and over: 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours. 
  • adults 65 years and over: 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. 
  • children 2 to under 6 years of age: 1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. 
  • children under 2 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)
  • Do not use if foil seal over mouth of the bottle is torn, broken or missing.
  • Gluten Free
  • Dosing cup should be washed and left to air dry after each use.
Inactive Ingredients

glacial acetic acid, glycerine, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, sucrose

Questions Or Comments?

1-833-688-7848

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
Principal Display Panel 

NDC 83745-188-24

Cetirizine Hydrochloride

Oral Solution 1 mg/mL

Antihistamine

INDOOR & OUTDOOR

ALLERGIES

(240 mL)

Grape  Flavored  Syrup

If Pregnant Or Breast Feeding:
  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use.
Active Ingredient (in Each 5 Ml Teaspoonful)       purpose

Cetirizine HCl 5 mg----------------------------------Antihistamine


Structured Label Content

Uses

temporarily relieves these symptoms due to hay fever or upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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)

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 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.

Purpose

Antihistamine

Directions
  • use only with enclosed dosing cup 
  • adults and children 6 years and over: 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours. 
  • adults 65 years and over: 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. 
  • children 2 to under 6 years of age: 1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. 
  • children under 2 years of age: ask a doctor 
  • consumers with liver or kidney disease: ask a doctor
Other Information (Other information)
  • store between 20° to 25°C (68° to 77°F)
  • Do not use if foil seal over mouth of the bottle is torn, broken or missing.
  • Gluten Free
  • Dosing cup should be washed and left to air dry after each use.
Inactive Ingredients (Inactive ingredients)

glacial acetic acid, glycerine, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, sucrose

Questions Or Comments? (Questions or comments?)

1-833-688-7848

When Using This Product (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
Principal Display Panel  (PRINCIPAL DISPLAY PANEL )

NDC 83745-188-24

Cetirizine Hydrochloride

Oral Solution 1 mg/mL

Antihistamine

INDOOR & OUTDOOR

ALLERGIES

(240 mL)

Grape  Flavored  Syrup

If Pregnant Or Breast Feeding: (If pregnant or breast-feeding:)
  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use.
Active Ingredient (in Each 5 Ml Teaspoonful)       purpose (Active ingredient (in each 5 mL teaspoonful)       Purpose)

Cetirizine HCl 5 mg----------------------------------Antihistamine


Advanced Ingredient Data


Raw Label Data

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