LORATADINE by Strides Pharma Inc / Tenshi Kaizen Pvt Ltd LORATADINE tablet

LORATADINE by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Loratadine 5 mg

Purpose

Antihistamine

Uses

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

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

Warnings

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

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

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 right away.

Directions

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

• adults and children 6 years and over: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
• children under 6 years of age: ask a doctor
• consumers with liver or kidney disease: ask a doctor

Other information

• safety sealed: do not use if the individual blister unit imprinted with Loratadine Orally disintegrating Tablet, USP is open or torn
• store between 20° to 25°C (68° to 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?

1-877-244-9825 - Our Medical Information center shall operate between 9:00 AM to 5:00 PM EST from Monday through Friday (business hours). Queries received outside business hours shall reach voice mail and shall be attended on next business day.

SPL UNCLASSIFIED SECTION

Manufactured by:

Tenshi Kaizen Private Limited

Bengaluru Rural – 562112, India

Distributed by:

Strides Pharma Inc.

East Brunswick, NJ 08816.

Revised: 09/2020

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LORATADINE 
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59556-301
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	5 mg

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

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	12mm
Flavor	PEPPERMINT	Imprint Code	T5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59556-301-01	1 in 1 CARTON	08/10/2021
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 59556-301-02	2 in 1 CARTON	08/10/2021
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 59556-301-03	3 in 1 CARTON	08/10/2021
3		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 59556-301-04	4 in 1 CARTON	08/10/2021
4		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC: 59556-301-05	5 in 1 CARTON	08/10/2021
5		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
6	NDC: 59556-301-06	6 in 1 CARTON	08/10/2021
6		10 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	ANDA212795	08/10/2021

Labeler - Strides Pharma Inc (078868278)

Establishment
Name	Address	ID/FEI	Business Operations
Tenshi Kaizen Pvt Ltd		675478488	analysis(59556-301) , manufacture(59556-301) , pack(59556-301)