Active Ingredients And Purpose
Active ingredient (in each 5 mL teaspoonful) Purpose
Cetirizine HCl 5 mg----------------------------------Antihistamine
Purpose
Antihistamine
Cetirizine Hydrochloride Oral Solution 1 mg/mL
- Manufacturer
- APOZEAL PHARMACEUTICALS INC
- Effective date
- 2026-05-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 01:57:57
Key Label Information
Uses
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
Warnings
Warnings
Directions And Dosage
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 Label Information
Other information
Store between 20° to 25°C (68° to 77°F). Excursions permitted to 15°–30°C (59°–86°F) [see USP Controlled Room Temperature]. Tamper Evident Do not use if foil seal over mouth of the bottle is torn, broken or missing 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 *This product is not manufactured or distributed by McNeil Consumer Healthcare, Division of McNeil-PPC, Inc., distributor of Children’s Zyrtec ® .
PRINCIPAL DISPLAY PANEL
NDC 83745- 188 -12 Cetirizine Hydrochloride Oral Solution, USP 1mg/mL Grape Flavored Syrup 120 mL NDC 83745- 188 -24 Cetirizine Hydrochloride Oral Solution, USP 1mg/mL Grape Flavored Syrup 120 mL
Products
- Cetrizine Hydrochloride
- CETIRIZINE
NDC Codes
Ingredients
Complete SPL Sections
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each 5 mL teaspoonful) Purpose
Cetirizine HCl 5 mg----------------------------------Antihistamine
Purpose
Antihistamine
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
Warnings
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). Excursions permitted to 15°–30°C (59°–86°F) [see USP Controlled Room Temperature]. Tamper Evident Do not use if foil seal over mouth of the bottle is torn, broken or missing 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 *This product is not manufactured or distributed by McNeil Consumer Healthcare, Division of McNeil-PPC, Inc., distributor of Children’s Zyrtec ® .
SPL UNCLASSIFIED SECTION
Distributed by: Apozeal Pharmaceuticals Inc. Hartel St, Levittown PA 19057
PRINCIPAL DISPLAY PANEL
NDC 83745- 188 -12 Cetirizine Hydrochloride Oral Solution, USP 1mg/mL Grape Flavored Syrup 120 mL NDC 83745- 188 -24 Cetirizine Hydrochloride Oral Solution, USP 1mg/mL Grape Flavored Syrup 120 mL
Source Document
Official SPL XML cached by FDA.report · DailyMed PDF
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- XML SHA-256
- e023cae580b38bb9a0872240a8c777dd6237aabce0e4e516896c6f9f868d8336
- XML bytes
- 36860
Legacy File Index
| Folder | File | Date |
|---|---|---|
| otc | 4af0cd5e-46c5-4571-9e04-b8bf16f21b50.xml | 2026-02-01 |
| otc | containerlabel240ml.jpg | 2026-02-01 |