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 Advanced Rx 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 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 useif you have ever had an allergic reaction to this product or any of its ingredients.
Otc - Ask Doctor
Ask a doctor before use ifyou haveliver or kidney disease. Your doctor should determine if you need a different dose.
Otc - When Using
When using this productdo not take more than directed. Taking more than directed may cause drowsiness.
Otc - Stop Use
Stop use and ask doctor ifan 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 (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
- store between 20° and 25°C (68° and 77°F)
- protect from excessive moisture
Inactive Ingredients
lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate
Questions?
call 1-800-630-8895
Principal Display Panel
NDC 80513-711-03
Compare to the Active Ingredient in Claritin ®*
Loratadine 10 mg
Allergy Relief
Non-Drowsy**
Antihistamine
24 Hour Relief of:
- Sneezing, runny nose
- Itchy, watery eyes
- Itchy throat or nose
Original Prescription Strength
**When Taken as Directed. See Drug Facts Panel.
300 Tablets
DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED
*This product is not manufactured or distributed by the owner of the registered trademark Claritin ®
Distributed by:
ADVANCED RX LLC,
1942 NE 163rd St
North Miami Beach,
FL 33162 U.S.A.
* Please review the disclaimer below.
