LORATADINE tablet, orally disintegrating

LORATADINE by

Drug Labeling and Warnings

LORATADINE by is a Otc medication manufactured, distributed, or labeled by Tenshi Kaizen Pvt Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient (in each tablet)

Loratadine 10 mg

Purpose

Antihistamine

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

Warnings

Do not useif you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a different dose.

When using this productdo not use more than directed. Taking more than recommended may cause drowsiness.

Stop use and ask a doctor ifan 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 right away.

Directions

• Place 1 tablet on tongue; tablet disentigrates with or without water.

adults and children 6 years and over	1 tablet daily; do not use more than 1 tablet in 24 hours
children under 6 years of age	ask a doctor
consumers who have liver or kidney disease	ask a doctor

Other information

• safety sealed: do not use if the individual blister unit printed with Loratadine orally disintegrating tablet is open or torn
• store at 20-25°C (68-77°F)
• use tablet immediately after opening individual blister
• complies with USP Procedure 2 for Assay and Organic Impurities and Test 2 for Disintegration

Inactive ingredients

anhydrous citric acid, mannitol, peppermint flavor, polysorbate 80, pullulan

Questions or comments?

Call Toll-free weekdays 9 AM to 5 PM EST at 1-888-375-3784

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Manufactured By: Tenshi Kaizen Private Limited

Bengaluru Rural - 562112, India

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Blister Pack Carton

NEW FORMULA

NON-DROWSY*

ALLERGY RELIEF

Loratadine Orally Disintegrating Tablet USP, 10 mg
Antihistamine

Indoor/Outdoor

ALLERGIES

24 Hour Relief of

Sneezing, Runny Nose

Itchy/Watery Eyes

Itchy Throat or Nose

Melts In Your Mouth

FRESH MINT Flavor

*When taken as directed. See Drug Facts Panel.

60 Orally Disintegrating Tablets

INGREDIENTS AND APPEARANCE

LORATADINE 
loratadine tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72983-503
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
MANNITOL (UNII: 3OWL53L36A)
PULLULAN (UNII: 8ZQ0AYU1TT)

Product Characteristics
Color	white (white to off- white)	Score	no score
Shape	ROUND	Size	12mm
Flavor	MINT	Imprint Code	M24
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72983-503-06	60 in 1 CARTON	05/07/2024
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA213294	05/07/2024

Labeler - Tenshi Kaizen Pvt Ltd (675478488)

Establishment
Name	Address	ID/FEI	Business Operations
Tenshi Kaizen Pvt Ltd		675478488	analysis(72983-503) , manufacture(72983-503) , pack(72983-503)