Loratadine by Advanced Rx LLC / Granules India Limited LORATADINE tablet

Loratadine by

Drug Labeling and Warnings

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

Drug Details [pdf]

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 useif you have ever had an allergic reaction to this product or any of its ingredients.

ASK DOCTOR

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

WHEN USING

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

STOP USE

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

PREGNANCY OR BREAST FEEDING

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

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 (1-800-222-1222) 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

• store between 20° and 25°C (68° and 77°F)
• protect from excessive moisture

Inactive ingredients​

lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate

Questions?

call 1-800-630-8895

PRINCIPAL DISPLAY PANEL

NDC: 80513-711-03

Compare to the Active Ingredient in Claritin ®*

Loratadine 10 mg

Allergy Relief

Non-Drowsy**

Antihistamine

24 Hour Relief of:

• Sneezing, runny nose
• Itchy, watery eyes
• Itchy throat or nose

Original Prescription Strength

**When Taken as Directed. See Drug Facts Panel.

300 Tablets

DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

*This product is not manufactured or distributed by the owner of the registered trademark Claritin ®

Distributed by:

ADVANCED RX LLC,

1942 NE 163rd St

North Miami Beach,

FL 33162 U.S.A.

INGREDIENTS AND APPEARANCE

LORATADINE 
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80513-711
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
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
STARCH, CORN (UNII: O8232NY3SJ)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	G;10
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80513-711-03	300 in 1 BOTTLE; Type 0: Not a Combination Product	08/07/2024
2	NDC: 80513-711-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2024

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

Labeler - Advanced Rx LLC (042795108)

Establishment
Name	Address	ID/FEI	Business Operations
Granules India Limited		918609236	manufacture(80513-711)