Loratadine Orally Disintegrating Tablets Usp 10 Mg

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

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?

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.

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

NDC 49035-806-09

equate^TM

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

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?)

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.

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)

NDC 49035-806-09

equate^TM

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

Advanced Ingredient Data

[{"name": "LORATADINE", "unii": "7AJO3BO7QN", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "ASPARTAME", "unii": "Z0H242BBR1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSPOVIDONE (15 MPA.S AT 5%)", "unii": "68401960MK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MANNITOL", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEPPERMINT", "unii": "V95R5KMY2B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STEARYL FUMARATE", "unii": "7CV7WJK4UI", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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": "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?": "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.", "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": "NDC 49035-806-09 equate TM 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"}

Loratadine Orally Disintegrating Tablets Usp 10 Mg

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information