FDA Label for Loratadine
View Indications, Usage & Precautions
Loratadine Product Label
The following document was submitted to the FDA by the labeler of this product Strides Pharma 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)
Loratadine 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
Otc - Do Not Use
Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
Otc - Ask Doctor
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
Otc - When Using
When using this product do not take more than directed. Taking more than directed may cause drowsiness.
Otc - Stop Use
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
adults and children 6 years and over | 1 capsule daily; not more than 1 capsule in 24 hours |
children under 6 years of age | ask a doctor |
consumers with liver or kidney disease | ask a doctor |
Other Information
- safety sealed: do not use if the individual blister unit imprinted with Loratadine capsule is open or torn
- store between 20° to 25°C (68° to 77°F)
- protect from freezing
Inactive Ingredients
FD & C Blue 1, Gelatin, Glycerin, Glyceryl Monocaprylocaprate, Isopropyl alcohol, Medium chain triglyceride, Polysorbate 80, Povidone K-30, Purified Water, Soya Lecithin, Sorbitol Solution,
Printing ink white-edible oil-Dewaxed Bleached Shellac Resins, Propylene Glycol, Sodium Lauryl Sulphate, Titanium Dioxide
.
Questions Or Comments?
Strides Pharma Inc. at 1-877-244-9825 or go to www.strides.com
Manufactured by:
Strides Pharma Science Limited
Bengaluru – 562106, India.
Distributed by:
Strides Pharma Inc.
East Brunswick, NJ 08816
Revised: 01/2020
* Please review the disclaimer below.