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 A-s Medication Solutions. 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 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
Warnings
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
- safety sealed: do not use if induction seal, with "Lift N Peel" tab, under cap is broken or missing
- store between 2°C and 30°C (36°F and 86°F)
- protect from excessive moisture
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose
How Supplied
Product: 50090-0838
NDC: 50090-0838-0 10 TABLET in a BOTTLE
NDC: 50090-0838-1 20 TABLET in a BOTTLE
NDC: 50090-0838-3 15 TABLET in a BOTTLE
NDC: 50090-0838-4 30 TABLET in a BOTTLE
NDC: 50090-0838-5 90 TABLET in a BOTTLE
NDC: 50090-0838-6 7 TABLET in a BOTTLE
Questions Or Comments?
Call 1-800-706-5575, weekdays, 8:30 am - 5:00 pm Eastern Standard Time
| Manufactured by: | Manufactured for: |
| Apotex Inc. | Apotex Corp. |
| Toronto, Ontario | Weston, Florida |
| Canada M9L 1T9 | 33326 |
Revised: August 2018
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