FDA Label for Loratadine 10 Mg
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- 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 INGREDIENT
- QUESTIONS OR COMMENTS?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Loratadine 10 Mg Product Label
The following document was submitted to the FDA by the labeler of this product Time Cap 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)
Loratadine USP, 10 mg
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- sneezing
- 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.
Ask A Doctor Before Use If You Have
liver or kidney disease. Your doctor should determine if you need a different dose.
When Using This Product
do not take more than directed. Taking more than directed may cause drowsiness
Stop Use And Ask A Doctor If
an allergic reaction to this product occurs. Seek medical help right away.
If Pregnant Or Breast-Feeding,
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: 1 tablet daily; not more than 1 tablet in 24 hours
- children under 6 years of age: ask a doctor
- consumers with liver or kidney disease: ask a doctor
Other Information
- Tamper evident: do not use this product if the imprinted foil seal over the mouth of the bottle is cut, torn, broken or missing.
- store between 20° to 25° C (68° to 77° F)
- FDA approved dissolution test specifications differ from USP
Inactive Ingredient
colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate
Questions Or Comments?
Call 1-877-290-4008
Package Label.Principal Display Panel
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