Dye Free Children's Cetirizine Hydrochloride

Dye Free Children's Cetirizine Hydrochloride
SPL v3
SPL
SPL Set ID 6a7c4dff-66c6-4d0c-af10-d908c65a43be
Route
ORAL
Published
Effective Date 2025-02-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetirizine (5 mg)
Inactive Ingredients
Anhydrous Citric Acid Propylene Glycol Water Sodium Benzoate Sorbitol Sucralose

Identifiers & Packaging

Marketing Status
ANDA Active Since 2016-10-26
Description

5 mg/5 mL Grape Flavor For Hospital Use Only LI1660 Rev.10/24 Drug Facts

Purpose

Antihistamine

How Supplied

NDC 68094-004-62 5 mL per unit dose cup Thirty (30) cups per shipper

Medication Information

Purpose

Antihistamine

How Supplied

NDC 68094-004-62

5 mL per unit dose cup

Thirty (30) cups per shipper

Description

5 mg/5 mL Grape Flavor For Hospital Use Only LI1660 Rev.10/24 Drug Facts

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
Section 42229-5

5 mg/5 mL Grape Flavor

For Hospital Use Only

LI1660 Rev.10/24

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.

Section 53414-9

If pregnant or breast-feeding:

  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use.
Directions
  • Use as directed per healthcare professional.
  • mL = milliliter
adults and children 6 years and over 5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours.
adults 65 years and over 5 mL once daily; do not take more than 5 mL in 24 hours.
children 2 to under 6 years of age 2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 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)
Inactive Ingredients

anhydrous citric acid, artificial grape flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

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
Active Ingredient (in Each 5 Ml)

Cetirizine HCl 5 mg

Principal Display Panel 5 Ml Cup Label

NDC 68094-004-59

PrecisionDose ™

Children's CETIRIZINE HCl

Oral Solution

5 mg/5 mL

DYE

FREE

Pkg: Precision Dose, Inc., S. Beloit, IL 61080

Structured Label Content

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
Section 42229-5 (42229-5)

5 mg/5 mL Grape Flavor

For Hospital Use Only

LI1660 Rev.10/24

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.

Section 53414-9 (53414-9)

If pregnant or breast-feeding:

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

Antihistamine

Directions
  • Use as directed per healthcare professional.
  • mL = milliliter
adults and children 6 years and over 5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours.
adults 65 years and over 5 mL once daily; do not take more than 5 mL in 24 hours.
children 2 to under 6 years of age 2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours.
children under 2 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
How Supplied

NDC 68094-004-62

5 mL per unit dose cup

Thirty (30) cups per shipper

Other Information
  • store between 20° to 25°C (68° to 77°F)
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, artificial grape flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

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
Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Cetirizine HCl 5 mg

Principal Display Panel 5 Ml Cup Label (PRINCIPAL DISPLAY PANEL - 5 mL Cup Label)

NDC 68094-004-59

PrecisionDose ™

Children's CETIRIZINE HCl

Oral Solution

5 mg/5 mL

DYE

FREE

Pkg: Precision Dose, Inc., S. Beloit, IL 61080

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:33.306968 · Updated: 2026-03-14T23:07:31.529158