NDC 53808-0457 Loratadine
Product Information
What is NDC 53808-0457?
The NDC code 53808-0457 is assigned by the FDA to the product Loratadine which is product labeled by State Of Florida Doh Central Pharmacy. The product's dosage form is and is administered via form. The product is distributed in a single package with assigned NDC code 53808-0457-1 30 tablet in 1 blister pack . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.
What are the uses for Loratadine?
This medication is an antihistamine that treats symptoms such as itching, runny nose, watery eyes, and sneezing from "hay fever" and other allergies. It is also used to relieve itching from hives. Loratadine does not prevent hives or prevent/treat a serious allergic reaction (anaphylaxis). Therefore, if your doctor has prescribed epinephrine to treat allergic reactions, always carry your epinephrine injector with you. Do not use loratadine in place of your epinephrine. If you are self-treating with this medication, it is important to read the manufacturer's package instructions carefully so you know when to consult your doctor or pharmacist. (See also Precautions section.) If you are using the tablets or capsules, do not use in children younger than 6 years unless directed by the doctor. If you are using the liquid or chewable tablets, do not use in children younger than 2 years unless directed by the doctor.
Product Characteristics
Color(s) | WHITE (C48325) |
Shape | OVAL (C48345) |
Size(s) | 6 MM |
Imprint(s) | L612 |
Score | 1 |
Product Details
Loratadine Active Ingredients UNII Codes
- LORATADINE (UNII: 7AJO3BO7QN)
- LORATADINE (UNII: 7AJO3BO7QN) (Active Moiety)
NDC to RxNorm Crosswalk
- RxCUI: 311372 - loratadine 10 MG 24HR Oral Tablet
- RxCUI: 311372 - loratadine 10 MG Oral Tablet
- RxCUI: 311372 - loratadine 10 MG 24 HR Oral Tablet
Loratadine Inactive Ingredients UNII Codes
- LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
- SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
* Please review the disclaimer below.
Patient Education
Loratadine
Loratadine is pronounced as (lor at' a deen)
Why is loratadine medication prescribed?
Loratadine is used to temporarily relieve the symptoms of hay fever (allergy to pollen, dust, or other substances in the air) and other allergies. These symptoms include ...
[Read More]
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Loratadine Product Label
FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Product Label Table of Contents
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- HOW SUPPLIED
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- 10 MG LABEL
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
How Supplied
They are supplied by State of Florida DOH Central Pharmacy as follows:
NDC | Strength | Quantity/Form | Color | Source Prod. Code |
53808-0457-1 | 10 mg | 30 Tablets in a Blister Pack | WHITE | 45802-0650 |
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 or kidney disease | ask a doctor |
Other Information
- Safety sealed: do not use if the imprinted bottle seal is open or torn.
Inactive Ingredients
Lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.
Questions Or Comments?
1 800 719-9260
10 Mg Label
NDC 53808-0457-1 Non-Drowsy*
LORAtadine
Tablets, USP
10 mg
Antihistamine
Indoor & Outdoor Allergies
24 Hour
Relief of:
• Sneezing
• Runny Nose
• Itchy, Watery
Eyes
• Itchy Throat
or Nose
* When taken as directed.
See Drug Facts Panel.
* Please review the disclaimer below.