Major Pharmaceuticals Children’s Cetirizine Hydrochloride Oral Solution Drug Facts

Manufacturer
ATLANTIC BIOLOGICALS CORP.
Effective date
2026-05-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:55:59

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

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 2yrs & older Dosing Cup Included Dye-Free Sugar-Free Grape Flavored Syrup

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

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 2yrs & older Dosing Cup Included Dye-Free Sugar-Free Grape Flavored Syrup

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

FolderFileDate
otc17856-6765-01 Rev. 1 Case Label.jpg2024-12-15
otc17856-6765-01 Rev. 1 Label.jpg2024-12-15
otc8cf2f8e1-4cbe-440f-9e61-3c1c0e19c4fc.xml2024-12-15