loratadine orally disintegrating tablets usp 10 mg

loratadine orally disintegrating tablets usp 10 mg
SPL v1
SPL
SPL Set ID a6e04fe7-23d3-47d7-9f18-5c4298fbc28b
Route
oral
Published
Effective Date 2022-06-20
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 2022-06-18

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?

call 1-855-274-4122



Distributed by:

AUROHEALTH LLC

279 Princeton-Hightstown Road

East Windsor, NJ 08520

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.

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 60 (6 X 10) Orally Disintegrating Tablets

Healthy LivingTM

Original Prescription Strength        *When taken as directed. See Drug Facts Panel.

LORATADINE

orally disintegrating tablets USP 10 mg

Antihistamine

Non-Drowsy

Indoor & Outdoor Allergies

Compare

to the Active

Ingredient in

Claritin®

RediTabs®

24 Hour                                                                     ACTUAL SIZE

                                                                                      60 (6 X 10)

• Relief of sneezing, runny nose, itchy,

  watery eyes & itchy throat or nose                        Orally Disintegrating

• No water needed — melts in your mouth                        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?)

call 1-855-274-4122



Distributed by:

AUROHEALTH LLC

279 Princeton-Hightstown Road

East Windsor, NJ 08520

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.

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 60 (6 X 10) Orally Disintegrating Tablets (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg, Blister Carton 60 (6 X 10) Orally Disintegrating Tablets)

Healthy LivingTM

Original Prescription Strength        *When taken as directed. See Drug Facts Panel.

LORATADINE

orally disintegrating tablets USP 10 mg

Antihistamine

Non-Drowsy

Indoor & Outdoor Allergies

Compare

to the Active

Ingredient in

Claritin®

RediTabs®

24 Hour                                                                     ACTUAL SIZE

                                                                                      60 (6 X 10)

• Relief of sneezing, runny nose, itchy,

  watery eyes & itchy throat or nose                        Orally Disintegrating

• No water needed — melts in your mouth                        Tablets


Advanced Ingredient Data


Raw Label Data

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