FDA Label for Loratadine Odt
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 INGREDIENTS
- QUESTIONS OR COMMENTS?
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 MG, BLISTER CARTON (10 ORALLY DISINTEGRATING TABLETS)
Loratadine Odt Product Label
The following document was submitted to the FDA by the labeler of this product Aurohealth 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.
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
- 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.
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 (1-800-222-1222) right away.
Directions
- place 1 tablet on tongue; tablet disintegrates, with or without water
| 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
- Phenylketonurics: Contains phenylalanine 2.25 mg per tablet
- do not use if the individual blister unit is open or torn
- store at 20° to 25°C (68° to 77°F)
- use tablet immediately after opening individual blister
- Complies with USP test 2 for Disintegration
Inactive Ingredients
aspartame, crospovidone, mannitol, microcrystalline cellulose, peppermint, pregelatinized starch (maize), sodium stearyl fumarate
Questions Or Comments?
call 1-855-274-4122
Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648
Made in India
Code: TS/DRUGS/22/2009
Package Label-Principal Display Panel - 10 Mg, Blister Carton (10 Orally Disintegrating Tablets)
NDC 58602-830-83
Primary Health
COMPARE TO Claritin℗ RediTabs℗Active ingredient**
FOR CHILDREN SIX YEARS
OF AGE OR OLDER
Children's
Non-Drowsy*
Allergy Relief
Loratadine Orally Disintegrating Tablets USP 10 mg
Antihistamine
Indoor & Outdoor Allergies
Original Prescription Strength
24 HOUR
Relief of:
• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose
No Water Needed
Melts in Your Mouth
*When taken as directed. See Drug Facts Panel.
10 Orally Disintegrating Tablets
* Please review the disclaimer below.