LORATADINE capsule, liquid filled

Loratadine by

Drug Labeling and Warnings

Loratadine by is a Otc medication manufactured, distributed, or labeled by Strides Pharma Inc, Strides Pharma Science Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each capsule)

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

OTC - DO NOT USE

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

OTC - ASK DOCTOR

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

OTC - WHEN USING

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

OTC - STOP USE

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

OTC - PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

OTC - 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 right away.

Directions

• adults and children 6 years and over: 1 capsule daily; not more than 1 capsule 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 capsule is open or torn
• store between 20° to 25°C (68° to 77°F)
• protect from freezing

Inactive ingredients

FD & C Blue 1, Gelatin, Glycerin, Glyceryl Monocaprylocaprate, Isopropyl alcohol, Medium chain triglyceride, Polysorbate 80, Povidone K-30, Purified Water, Soya Lecithin, Sorbitol Solution,

Printing ink white-edible oil-Dewaxed Bleached Shellac Resins, Propylene Glycol, Sodium Lauryl Sulphate, Titanium Dioxide

.

Questions or comments?

Strides Pharma Inc. at 1-877-244-9825 or go to www.strides.com

Manufactured by:

Strides Pharma Science Limited

Bengaluru – 562106, India.

Distributed by:

Strides Pharma Inc.

East Brunswick, NJ 08816

Revised: 01/2020

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LORATADINE 
loratadine capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59556-882
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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
NONCRYSTALLIZING SORBITOL SOLUTION (UNII: 9E0S3UM200)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POVIDONE K30 (UNII: U725QWY32X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BLUE	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	10
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59556-882-81	3 in 1 CARTON	06/01/2021
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 59556-882-01	1 in 1 CARTON	06/01/2021
2		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	ANDA211926	06/01/2021

Labeler - Strides Pharma Inc (078868278)

Registrant - Strides Pharma Science Limited (650738743)

Establishment
Name	Address	ID/FEI	Business Operations
Strides Pharma Science Limited		918513263	ANALYSIS(59556-882) , MANUFACTURE(59556-882) , PACK(59556-882)