FDA Label for Cetirizine Hydrochloride
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH 5 ML TEASPOONFUL)
- PURPOSE
- USES
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- WHEN USING THIS PRODUCT
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- OTHER
- PRINCIPAL DISPLAY PANEL - 118 ML BOTTLE LABEL
Cetirizine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Taro Pharmaceutical Industries, Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each 5 Ml Teaspoonful)
Cetirizine HCl 5 mg
Purpose
Antihistamine
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
Otc - Do Not Use
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.
Otc - Ask Doctor
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
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.
Otc - Stop Use
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding:
- if breastfeeding: not recommended
- if pregnant: ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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).
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 older: 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)
Inactive Ingredients
bubble gum artificial flavor, glacial acetic acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate anhydrous, sucralose
Questions?
Call 1-866-923-4914
Other
Dosing cup should be washed and left to air dry after each use. Do not use if carton is opened or if imprinted safety seal is torn or missing.
Dist. by:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532
Principal Display Panel - 118 Ml Bottle Label
NDC 51672-2106-8
Children's
Cetirizine
Hydrochloride
Oral Solution
1 mg/mL
Antihistamine
ALLERGY
Indoor & Outdoor Allergies
2 Yrs.
& older
Dye Free
Sugar Free
Bubble Gum Flavor
24
Hour
Relief of:
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
4 FL OZ (118 mL)
* Please review the disclaimer below.