FDA Label for Cetirizine Hydrochloride (allergy)
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH TABLET)
- 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?
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 MG (500'S TABLETS CONTAINER LABEL)
Cetirizine Hydrochloride (allergy) Product Label
The following document was submitted to the FDA by the labeler of this product Northstar Rx 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 Hydrochloride Tablets USP 10 mg (ALLERGY RELIEF)
Drug Facts
Active Ingredient (In Each Tablet)
Cetirizine hydrochloride 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 tablet once daily; do not take more than one 10 mg tablet 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 between 20° to 25°C (68° to 77°F)
- TAMPER EVIDENT: DO NOT USE IF SEAL OVER BOTTLE OPENING IS BROKEN OR MISSING
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide
Questions?
call 1-800-206-7821
Manufactured for: Northstar Rx LLC
Memphis, TN 38141
Manufactured by: Aurobindo Pharma Limited
Hyderabad-500 090, India
Code: TS/DRUGS/19/1993
Issued: 03/2018
Package Label-Principal Display Panel - 10 Mg (500'S Tablets Container Label)
NDC 16714-799-04
Cetirizine Hydrochloride
Tablets USP 10 mg
Antihistamine
ALLERGY RELIEF
Original Prescription Strength
Indoor & Outdoor Allergies
24 Hour Relief of :
• Sneezing • Runny Nose
• Itchy, Watery Eyes • Itchy Throat or Nose
500 Tablets
10 mg each
* Please review the disclaimer below.