FDA Label for Cetirizine Hydrochloride (allergy)
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH CAPSULE)
- PURPOSE
- USES
- WARNINGS
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING:
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 MG (65'S CAPSULE CONTAINER LABEL)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 MG (65'S CAPSULE CONTAINER CARTON LABEL)
Cetirizine Hydrochloride (allergy) Product Label
The following document was submitted to the FDA by the labeler of this product Aurohealth Llc. 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.
Other
Cetirizine HCl Capsules 10 mg (Allergy)
Drug Facts
Active Ingredient (In Each Capsule)
Cetirizine HCI USP 10 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
Warnings
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
Stop Use And Ask A Doctor If
an allergic reaction to this product occurs. Seek medical help right away.
If Pregnant Or Breast-Feeding:
- If breast-feeding: not recommended
- if pregnant: ask a health professional before use.
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
| adults and children 6 years and over | one 10 mg capsule once daily; do not take more than one 10 mg capsule in 24 hours. A 5 mg product may be appropriate for less severe symptoms. |
| adults 65 years and over | ask a doctor |
| children under 6 years of age | ask a doctor |
| consumers with liver or kidney disease | ask a doctor |
Other Information
- store at 20°-25°C (68°-77°F)
- avoid high humidity and excessive heat above 40°C (104°F)
- protect from light
- do not use if seal imprinted with SEALED for YOUR PROTECTION under the bottle cap is broken or missing.
Inactive Ingredients
gelatin, glycerin, polyethylene glycol, purified water, sodium hydroxide, sorbitol sorbitan solution
Questions Or Comments?
call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST)
Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Made in India
Code: TS/DRUGS/16/2014
Package Label-Principal Display Panel - 10 Mg (65'S Capsule Container Label)
Healthy LivingTM
Allergy Original Prescription Strength
CETIRIZINE HCl
Capsules 10 mg
Antihistamine
Indoor + Outdoor Allergies
READ AND KEEP THE OUTER PACKAGE FOR 65 LIQUID GELS*
COMPLETE WORNINGS AND INFORMATION *liquid-filled capsules
Package Label-Principal Display Panel -10 Mg (65'S Capsule Container Carton Label)
Healthy LivingTM
Allergy Original Prescription Strength
CETIRIZINE HCl
Capsules 10 mg
Antihistamine
Indoor + Outdoor Allergies *Compare
to the Active
Ingredient in CZ10
Zyrtec® (Actual Size)
24 Hour Relief of: • Sneezing • Runny Nose 65 Liquid Gels*
• Itchy, Watery Eyes • Itchy Throat or Nose *liquid-filled capsules
* Please review the disclaimer below.