Major Pharmaceuticals Children’s Cetirizine Hydrochloride Oral Solution Drug Facts

Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2026-03-25
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:51:35

Key Label Information

Active Ingredients And Purpose

Active ingredient (in each 5 mL)

Cetirizine HCl 5 mg

Purpose

Antihistamine

Uses

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

Warnings

Directions And Dosage

Directions

• use only with enclosed dosing cup • find right dose on chart below • 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 Label Information

Inactive ingredients

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

Package/Label Principal Display Panel

COMPARE TO the active ingredient of CHILDREN’S ZYRTEC® Children’s Cetirizine Hydrochloride Oral Solution 1 mg/mL Antihistamine ALLERGY INDOOR & OUTDOOR ALLERGIES 24 HOUR RELIEF OF: Sneezing / Runny Nose Itchy, Watery Eyes / Itchy Throat or Nose 4 FL OZ 24 Hour (118 mL) 2yrs & older Dosing Cup Included Dye-Free Sugar-Free Grape Flavored Syrup Relabeled By: Preferred Pharmaceuticals Inc. NDC 68788-8188-1

Products

NDC Codes

Ingredients

Complete SPL Sections

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Cetirizine HCl 5 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

• use only with enclosed dosing cup • find right dose on chart below • 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO the active ingredient of CHILDREN’S ZYRTEC® Children’s Cetirizine Hydrochloride Oral Solution 1 mg/mL Antihistamine ALLERGY INDOOR & OUTDOOR ALLERGIES 24 HOUR RELIEF OF: Sneezing / Runny Nose Itchy, Watery Eyes / Itchy Throat or Nose 4 FL OZ 24 Hour (118 mL) 2yrs & older Dosing Cup Included Dye-Free Sugar-Free Grape Flavored Syrup Relabeled By: Preferred Pharmaceuticals Inc. NDC 68788-8188-1

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

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