Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 00608f79-20db-4a7d-a204-89779f01ad48
Route
ORAL
Published
Effective Date 2010-05-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loratadine (10 mg)
Inactive Ingredients
Lactose Monohydrate Magnesium Stearate Cellulose, Microcrystalline Sodium Starch Glycolate Type A Potato

Identifiers & Packaging

Pill Appearance
Imprint: L612 Shape: oval Color: white Size: 6 mm Score: 1
Marketing Status
ANDA Active Since 2009-07-01
Description

Loratadine, USP 10 mg

Purpose

Antihistamine

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

Medication Information

Purpose

Antihistamine

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
Description

Loratadine, USP 10 mg

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
Section 42229-5

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

Section 44425-7
  • Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature).
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
Do Not Use

if you have ever had an allergic reaction to this product or any of its ingredients.

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.

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

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.

Active Ingredient (in Each Tablet)

Loratadine, USP 10 mg

Ask A Doctor Before Use If You Have

liver or kidney disease.Your doctor should determine if you need a different dose.

Structured Label Content

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
Section 42229-5 (42229-5)

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

Section 44425-7 (44425-7)
  • Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature).
Purpose

Antihistamine

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
Do Not Use (Do not use)

if you have ever had an allergic reaction to this product or any of its ingredients.

10 Mg Label (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.

How Supplied (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
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? (Questions or comments?)

1 800 719-9260

When Using This Product (When using this product)

do not take more than directed. Taking more than directed may cause drowsiness.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if an allergic reaction to this product occurs. Seek medical help right away.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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.

Active Ingredient (in Each Tablet) (Active Ingredient (in each tablet))

Loratadine, USP 10 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver or kidney disease.Your doctor should determine if you need a different dose.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:06.483364 · Updated: 2026-03-14T22:52:26.166879