Loratadine by Granules India Limited LORATADINE tablet

Loratadine by

Drug Labeling and Warnings

Loratadine by is a Otc medication manufactured, distributed, or labeled by Granules India Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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 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

• 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

• Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
• store between 20° to 25°C (68° to 77°F)

INACTIVE INGREDIENTS

Lactose monohydrate, magnesium stearate, sodium starch glycolate and starch maize pregelatinized

QUESTIONS OR COMMENTS

Contact 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LORATADINE 
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62207-787
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
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	white (White to off white)	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	G;10
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62207-787-49	1000 in 1 BOTTLE; Type 0: Not a Combination Product	01/08/2020
2	NDC: 62207-787-88	5 in 1 BOX	03/16/2020
2		20000 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA210722	01/08/2020

Labeler - Granules India Limited (915000087)

Establishment
Name	Address	ID/FEI	Business Operations
Granules India Limited		918609236	analysis(62207-787) , manufacture(62207-787)