loratadine orally disintegrating tablets usp 10 mg

loratadine orally disintegrating tablets usp 10 mg
SPL v4
SPL
SPL Set ID f399f7ab-ab51-46ff-bce9-3014eb021930
Route
oral
Published
Effective Date 2022-11-04
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
loratadine (10 mg)
Inactive Ingredients
aspartame crospovidone (15 mpa.s at 5%) 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 2018-04-11

Purpose

Antihistamine

Description

Loratadine USP 10 mg


Medication Information

Active Ingredient

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
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

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

Description

Loratadine USP 10 mg

Do Not Use

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

Questions Or Comments?

DISTRIBUTED BY: Walmart Inc,.

Bentonville, AR 72716

This Product is not manufactured or distributed

by Bayer HealthCare LLC, distributor of claritin®RediTabs®



Manufactured for :

AUROHEALTH LLC

2572 Brunswick Pikg

Lawrenceville, NJ 08684



Manufactured by :

Aurobindo Pharma Limited

Unit- VII (SEZ)

Mahabubnagar (Dt) -509302

India

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.

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

NDC 49035-806-09

equateTM

 

Compared to

the active        

Ingredient

In Claritin®

RediTabs®**

 

Non-Drowsy*

Loratadine Orally Disintegrating                      Dissolves

Tablets USP 10 mg                                          in Your Mouth

Antihistamine

Indoor & Outdoor Allergy Relief

24 Hour Relief Of:

  • Sneezing
  • Runny nose                                              24
  • Itchy, watery eyes                                 HOUR
  • Itchy throat or nose

Original  Prescription Strength                                                 

                                                                                             30    

*When taken as directed. See Drug Facts Panel.     TABLETS   (3 x 10) Orally Disintegrating Tablets






Structured Label Content

Active Ingredient (Active ingredient (in each tablet))

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
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

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

Do Not Use (Do not use)

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

Questions Or Comments? (Questions or comments?)

DISTRIBUTED BY: Walmart Inc,.

Bentonville, AR 72716

This Product is not manufactured or distributed

by Bayer HealthCare LLC, distributor of claritin®RediTabs®



Manufactured for :

AUROHEALTH LLC

2572 Brunswick Pikg

Lawrenceville, NJ 08684



Manufactured by :

Aurobindo Pharma Limited

Unit- VII (SEZ)

Mahabubnagar (Dt) -509302

India

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.

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)

NDC 49035-806-09

equateTM

 

Compared to

the active        

Ingredient

In Claritin®

RediTabs®**

 

Non-Drowsy*

Loratadine Orally Disintegrating                      Dissolves

Tablets USP 10 mg                                          in Your Mouth

Antihistamine

Indoor & Outdoor Allergy Relief

24 Hour Relief Of:

  • Sneezing
  • Runny nose                                              24
  • Itchy, watery eyes                                 HOUR
  • Itchy throat or nose

Original  Prescription Strength                                                 

                                                                                             30    

*When taken as directed. See Drug Facts Panel.     TABLETS   (3 x 10) Orally Disintegrating Tablets






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