LORATADINE tablet, orally disintegrating

LORATADINE by

Drug Labeling and Warnings

LORATADINE by is a Otc medication manufactured, distributed, or labeled by CVS PHARMACY, INC, 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
• 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 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

• 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

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Manufactured by:

Tenshi Kaizen Private Limited

Bengaluru Rural – 562112, India

Revised: 11/2020

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Health

Indoor & Outdoor Allergies

Children’s

LORATADINE ORALLY

DISINTEGRATING

TABLETS USP, 10 mg

Antihistamine

Allergy Relief

Non-Drowsy*

Original Prescription Strength

24 hour relief of:

Sneezing; Runny nose; Itchy,

watery eyes; Itchy throat or nose

Ages 6 yrs & older

30 ORALLY

DISINTEGRATING

TABLETS

INGREDIENTS AND APPEARANCE

LORATADINE 
loratadine tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-503
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)
PULLULAN (UNII: 8ZQ0AYU1TT)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
MANNITOL (UNII: 3OWL53L36A)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	12mm
Flavor	MINT	Imprint Code	T10
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-503-02	2 in 1 CARTON	08/08/2021
1		20 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 51316-503-03	3 in 1 CARTON	08/08/2021
2		30 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 51316-503-05	5 in 1 CARTON	08/08/2021
3		50 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 51316-503-06	6 in 1 CARTON	08/08/2021
4		60 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC: 51316-503-04	4 in 1 CARTON	08/08/2021
5		40 in 1 BLISTER PACK; Type 0: Not a Combination Product
6	NDC: 51316-503-01	1 in 1 CARTON	08/08/2021
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	ANDA213294	08/08/2021

Labeler - CVS PHARMACY, INC (062312574)

Establishment
Name	Address	ID/FEI	Business Operations
Tenshi Kaizen Pvt Ltd		675478488	analysis(51316-503) , manufacture(51316-503) , pack(51316-503)