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 Innovative Manufacturing And Distribution Services, 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
Loratadine 10mg
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
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
- side effects occur.
You may report side effects to FDA at 1-800-FDA-1088.
If Pregnant Or Breastfeeding
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 or kidney disease: ask a doctor.
Other Information
- Safety sealed: do not use if the imprinted bottle seal is open or torn
- Store at 15° - 30° C (59° - 86° F).
Inactive Ingredients
Lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.
Package/Label Principal Display Panel
IMDS INC.
Loratadine
(Compare to Claritin®)
30 TABLETS
10 mg
Relief of: Sneezing, Runny Nose,
Itchy Watery Eyes, Itchy Throat or Nose
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