FDA Label for Levocetirizine Dihydrochloride
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING:
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- CARTON LABEL
- BOTTLE LABEL
Levocetirizine Dihydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Dr. Reddy's Laboratories 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 Tablet)
Levocetirizine dihydrochloride USP, 5 mg
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
Warnings
Do Not Use
- if you have kidney disease
- if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine
Ask A Doctor Before Use If You Have
- ever had trouble urinating or emptying your bladder
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 Doctor If
- you have trouble urinating or emptying your bladder
- an allergic reaction to this product occurs. Seek medical help right away.
If Pregnant Or Breast-Feeding:
- if breast-feding: 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 65 years of age and older |
|
adults and children 12-64 years of age |
|
children 6-11 years of age |
|
children under 6 years of age |
|
consumers with kidney disease |
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Other Information
- store between 20° and 25°C (68° and 77°F)
- (bottles only) safety sealed: do not use if carton was opened or if printed foil inner seal on bottle is torn or missing
- (blister only) safety sealed: do not use if seal is broken or if individual blister unit is open or torn
Inactive Ingredients
colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide
Questions Or Comments?
Call 1-888-375-3784
Carton Label
Bottle Label
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