Active Ingredient (In Each Tablet)
Loratadine 10 mg
Loratadine
FDA Label NDC 50090-0838
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by A-s Medication Solutions for the product Loratadine (NDC 50090-0838). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, warnings, directions, other information, inactive ingredients, how supplied, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
* Please review the disclaimer below.
