FDA Label for Loratadine Allergy Relief
View Indications, Usage & Precautions
Loratadine Allergy Relief Product Label
The following document was submitted to the FDA by the labeler of this product Marlex 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.
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Drug Facts
Manufactured for/ Distributed by:
Marlex Pharmaceuticals, Inc.
New Castle, DE 19720
Rev. 10/22 SP
Active Ingredient (In Each Tablet)
Loratadine, USP 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 use if you have ever had an allergic reaction to this product or any of its ingredients.
Otc - Ask Doctor
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
Otc - When Using
When using this product do not take more than directed. Taking more than directed may cause drowsiness.
Otc - Stop Use
Stop use and ask a doctor if an 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 right away (1-800-222-1222).
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° to 25° C (68° to 77° F)
- protect from excessive moisture
- TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
Inactive Ingredients
corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch
Principal Display Panel
Loratadine 10mg Tablets
NDC 10135-0763-30
30 Tablets
Loratadine 10mg Tablets
NDC 10135-0763-90
90 Tablets
Loratadine 10mg Tablets
NDC 10135-0763-03
300 Tablets
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