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Loratadine by State of Florida DOH Central Pharmacy

Medically reviewed on May 28, 2018

Dosage form: tablet
Ingredients: LORATADINE 10mg
Labeler: State of Florida DOH Central Pharmacy
NDC Code: 53808-0457

Drug Facts

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:

NDCStrengthQuantity/FormColorSource Prod. Code
53808-0457-110 mg30 Tablets in a Blister PackWHITE45802-0650

Warnings

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 over1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other Information
  • Safety sealed: do not use if the imprinted bottle seal is open or torn.

  • Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature).

Inactive Ingredients

Lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

Questions or comments?

1 800 719-9260

This product is manufactured by:

Perrigo Company
515 Eastern Avenue Allegan
Michigan 49010

This Product was Repackaged By:

State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
United States

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.

LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53808-0457(NDC:45802-0650)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (LORATADINE) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize6mm
FlavorImprint CodeL612
Contains    
Packaging
#Item CodePackage Description
1NDC:53808-0457-130 TABLET (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07630107/01/2009
Labeler - State of Florida DOH Central Pharmacy (829348114)
Establishment
NameAddressID/FEIOperations
State of Florida DOH Central Pharmacy829348114repack

 
State of Florida DOH Central Pharmacy

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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