Loratadine Tablets Usp 10 Mg

Loratadine Tablets Usp 10 Mg
SPL v3
SPL
SPL Set ID b96831f5-5e75-c526-e053-2995a90a36ad
Route
ORAL
Published
Effective Date 2021-04-08
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: 39;L Shape: round Color: white Size: 6 mm Score: 1
Marketing Status
ANDA Active Since 2021-03-15

Description

Loratadine USP 10 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

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
Warnings

Do not use



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

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


  • Tamper-evident: do not use if foil seal under cap, printed with “SEALED for YOUR PROTECTION” is missing, open or broken
  • store at 20° to 25°C (68° to 77°F)
  • protect from excessive moisture
Inactive Ingredients

lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate.

Questions Or Comments?


1-800-632-6900

 DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

MADE IN INDIA




Code: TS/DRUGS/22/2009

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 (1-800-222-1222) 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.

Package Label Principal Display Panel 10 Mg Container label (30 Tablets)

NDC 30142-066-09

Kroger®

Non-Drowsy*

Allergy Relief

24

HOUR

Loratadine
Tablets USP

10 mg/
Antihistamine



INDOOR & OUTDOOR

ALLERGIES


*When taken as directed. See Drug Facts Panel.

RELIEF OF:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose



30 TABLETS



Package Label Principal Display Panel 10 Mg Container Carton Label (30 Tablets)

COMPARE TO the active ingredient of CLARITIN® TABLETS **See bottom panel

NDC 30142-066-09

Kroger®

Non-Drowsy*

Allergy Relief

Loratadine
Tablets USP 10 mg/ Antihistamine



INDOOR & OUTDOOR ALLERGIES

RELIEF OF: Sneezing; Runny Nose

Itchy, Watery Eyes; Itchy Throat or Nose

*When taken as directed. See Drug Facts Panel.



24

HOUR



actual

size            L



30 TABLETS




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
Purpose

Antihistamine

Warnings

Do not use



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

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 (Other information)


  • Tamper-evident: do not use if foil seal under cap, printed with “SEALED for YOUR PROTECTION” is missing, open or broken
  • store at 20° to 25°C (68° to 77°F)
  • protect from excessive moisture
Inactive Ingredients (Inactive ingredients)

lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate.

Questions Or Comments? (Questions or comments?)


1-800-632-6900

 DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

MADE IN INDIA




Code: TS/DRUGS/22/2009

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 If (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 (1-800-222-1222) 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.

Package Label Principal Display Panel 10 Mg Container label (30 Tablets) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Container Label (30 Tablets))

NDC 30142-066-09

Kroger®

Non-Drowsy*

Allergy Relief

24

HOUR

Loratadine
Tablets USP

10 mg/
Antihistamine



INDOOR & OUTDOOR

ALLERGIES


*When taken as directed. See Drug Facts Panel.

RELIEF OF:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose



30 TABLETS



Package Label Principal Display Panel 10 Mg Container Carton Label (30 Tablets) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Container Carton Label (30 Tablets))

COMPARE TO the active ingredient of CLARITIN® TABLETS **See bottom panel

NDC 30142-066-09

Kroger®

Non-Drowsy*

Allergy Relief

Loratadine
Tablets USP 10 mg/ Antihistamine



INDOOR & OUTDOOR ALLERGIES

RELIEF OF: Sneezing; Runny Nose

Itchy, Watery Eyes; Itchy Throat or Nose

*When taken as directed. See Drug Facts Panel.



24

HOUR



actual

size            L



30 TABLETS




Advanced Ingredient Data


Raw Label Data

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