FDA Label for Loratadine Allergy Relief
View Indications, Usage & Precautions
- ACTIVE INGREDIENT(S)
- PURPOSE
- USE(S)
- 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
- 16 HOW SUPPLIED/STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL - 10 MG TABLET BOTTLE LABEL
Loratadine Allergy Relief Product Label
The following document was submitted to the FDA by the labeler of this product Pd-rx Pharmaceuticals, 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(S)
Loratadine USP, 10 mg
Purpose
Antihistamine
Use(S)
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
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 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 and kidney disease | ask a doctor |
Other Information
- store between 20 and 25° C (68 and 77° F)
- protect from excessive moisture
- TAMPER EVIDENT: DO NOT USE IF SEAL IS BROKEN OR MISSING FROM BOTTLE.
Inactive Ingredients
Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch
16 How Supplied/Storage And Handling
Loratadine tablets, 10 mg are supplied as white, film-coated, round biconvex tablets, debossed with “RX526”. In bottles of 90: (NDC 55289-728-90).
Principal Display Panel - 10 Mg Tablet Bottle Label
NDC 55289-728-90
* Please review the disclaimer below.