FDA Label for Allergy Relief
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH CAPSULE)
- PURPOSE
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- 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?
- PRINCIPAL DISPLAY PANEL
- PACKAGE LABELING
Allergy Relief Product Label
The following document was submitted to the FDA by the labeler of this product Assured / Dollar Tree (greenbrier International, Inc.). 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 Capsule)
Cetirizine HCl USP10 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
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.
Ask A Doctor Before Use If You Have
liver or kidney disease. Your doctor should determine if you need a different dose.
Ask A Doctor Or Pharmacist Before Use If You Are
taking tranquilizers or sedatives.
When Using This Product
- drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- 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 (1800-222-1222) right away.
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
Inactive Ingredients
gelatin, medium-chain triglycerides, polyethylene glycol 400, printing ink white (isopropyl alcohol, propylene glycol, shellac resins, sodium lauryl sulphate, titanium dioxide), purified water, sodium hydroxide, sorbitan, sorbitol solution
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
COMPARE TO THE ACTIVE INGREDIENTS IN ZYRTEX®*
ALL DAY
Allergy Relief
24-hour relief of indoor /outdoor allergy symptoms including:
- Runny nose
- Sneezing
- Itchy, watery eyes
- Itchy throat or nose
Antihistamine • Cetirizine HCI, 10 mg
softgels**
(**Liquid-Filled Capsules)
*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Zyrtec®.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY
GREENBRIER INTERNATIONAL, INC.
500 VOLVO PARKWAY, CHESAPEAKE , VA 23320
Package Labeling
ASSURED All Day Allergy Relief
* Please review the disclaimer below.