FDA Label for Loratadine
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- WARNINGS
- 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 INGREDIENTS
- QUESTIONS OR COMMENTS?
- PACKAGE LABEL- PRINCIPAL DISPLAY PANEL - 10MG (30 TABLETS BOTTLE)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 MG CONTAINER CARTON (30 TABLETS)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL- 10 MG BLISTER CARTON (100 TABLETS)
Loratadine Product Label
The following document was submitted to the FDA by the labeler of this product Bluepoint Laboratories. 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
Warnings
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 an overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
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 if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
store at 20°C to 25°C (68° to 77°F)
protect from excessive moisture
Inactive Ingredients
lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate.
Questions Or Comments?
call 1-855-274-4122
Manufactured by: Aurobindo Pharma Limited
Hyderabad-509 302,
INDIA
For BluePoint Laboratories
MADE IN INDIA
Code: TS/DRUGS/22/2009
Issued: 04/2020
Package Label- Principal Display Panel - 10Mg (30 Tablets Bottle)
NDC 68001-438-00
Non-Drowsy*
Loratadine
Tablets USP 10mg
Antihistamine
24 Hour
Relief of:
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose
Indoor & Outdoor
Allergies
# When taken as directed.
See Drug Facts Panel. 30 Tablets
Package Label-Principal Display Panel - 10 Mg Container Carton (30 Tablets)
NDC 68001-438-04
#Compare to the active ingredient in claritin®
Non-Drowsy*
Loratadine
Tablets USP 10mg
Antihisamine
Indoor and outdoor allergies
24 Hour
Relief of:
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose
*When taken as directed.
See Drug Facts Panel. 30 Tablets
Package Label-Principal Display Panel- 10 Mg Blister Carton (100 Tablets)
NDC 68001-438-96
#Compare to the active
ingredient in claritin®
Non-Drowsy*
Loratadine
Tablets USP 10mg
Antihisamine
Indoor and outdoor allergies
24 Hour
Relief of:
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose
*When taken as directed.
See Drug Facts Panel. 100 Tablets
* Please review the disclaimer below.