Loratadine Orally Disintegrating Tablets Usp 10 Mg

Loratadine Orally Disintegrating Tablets Usp 10 Mg
SPL v1
SPL
SPL Set ID f59f3400-da77-4eb7-be02-842071d87fae
Route
ORAL
Published
Effective Date 2022-10-06
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Loratadine (10 mg)
Inactive Ingredients
Aspartame Crospovidone (120 .mu.m) Mannitol Microcrystalline Cellulose Peppermint Starch, Corn Sodium Stearyl Fumarate

Identifiers & Packaging

Pill Appearance
Imprint: K;9 Shape: round Color: white Size: 8 mm Score: 1
Marketing Status
ANDA Active Since 2022-10-06

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
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
Directions


  • place 1 tablet on tongue; tablet disintegrates, with or without water 


 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.

Other Information
  • Phenylketonurics: Contains phenylalanine 2.25 mg per tablet
  • do not use if the individual blister unit is open or torn
  • store at 20° to 25°C (68° to 77°F)
  • use tablet immediately after opening individual blister
  • Complies with USP test 2 for Disintegration
Inactive Ingredients

aspartame, crospovidone, mannitol, microcrystalline cellulose,  peppermint, pregelatinized starch (maize), sodium stearyl fumarate

Questions Or Comments?

call 1-800-616-2471



Distributed by:

RUGBY® LABORATORIES

Indianapolis, IN 46268

www.majorpharmaceuticals.com



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, Blister Carton 30 (3 X 10) Orally Disintegrating Tablets

Rugby®                              



NDC 0536-1367-07

Compare to the

active ingredient in

Claritin® RediTabs®**

  

Original Prescription Strength     

Non-Drowsy*                          

Loratadine Orally Disintegrating            


Tablets USP                                              

10 mg                                                         

                                                                

Antihistamine                          



Indoor & Outdoor Allergies



24 Hour

NO WATER

NEEDED

MELTS IN

YOUR MOUTH



Relief of:

• Sneezing

• Runny Nose

• Itchy, Watery Eyes                               

• Itchy Throat or Nose

30 (3 X 10) Orally Disintegrating Tablets               



*When taken as directed. See Drug Facts Panel.


Structured Label Content

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
Purpose

Antihistamine

Directions


  • place 1 tablet on tongue; tablet disintegrates, with or without water 


 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.

Other Information (Other information)
  • Phenylketonurics: Contains phenylalanine 2.25 mg per tablet
  • do not use if the individual blister unit is open or torn
  • store at 20° to 25°C (68° to 77°F)
  • use tablet immediately after opening individual blister
  • Complies with USP test 2 for Disintegration
Inactive Ingredients (Inactive ingredients)

aspartame, crospovidone, mannitol, microcrystalline cellulose,  peppermint, pregelatinized starch (maize), sodium stearyl fumarate

Questions Or Comments? (Questions or comments?)

call 1-800-616-2471



Distributed by:

RUGBY® LABORATORIES

Indianapolis, IN 46268

www.majorpharmaceuticals.com



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, Blister Carton 30 (3 X 10) Orally Disintegrating Tablets (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg, Blister Carton 30 (3 X 10) Orally Disintegrating Tablets)

Rugby®                              



NDC 0536-1367-07

Compare to the

active ingredient in

Claritin® RediTabs®**

  

Original Prescription Strength     

Non-Drowsy*                          

Loratadine Orally Disintegrating            


Tablets USP                                              

10 mg                                                         

                                                                

Antihistamine                          



Indoor & Outdoor Allergies



24 Hour

NO WATER

NEEDED

MELTS IN

YOUR MOUTH



Relief of:

• Sneezing

• Runny Nose

• Itchy, Watery Eyes                               

• Itchy Throat or Nose

30 (3 X 10) Orally Disintegrating Tablets               



*When taken as directed. See Drug Facts Panel.


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Raw Label Data

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