LORATADINE ALLERGY RELIEF- loratadine tablet

Loratadine Allergy Relief by

Drug Labeling and Warnings

Loratadine Allergy Relief by is a Otc medication manufactured, distributed, or labeled by RPK Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(S)

Loratadine USP, 10 mg

PURPOSE

Antihistamine

USE(S)

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

• 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 and kidney disease: ask a doctor

OTHER INFORMATION

• store between 20 and 25° C (68 and 77° F)
• protect from excessive moisture
• TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.

INACTIVE INGREDIENTS

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

QUESTIONS?

Call 1-800-406-7984

HOW SUPPLIED

Product: 53002-7490

NDC: 53002-7490-9 5 TABLET in a BOTTLE

NDC: 53002-7490-1 10 TABLET in a BOTTLE

NDC: 53002-7490-5 15 TABLET in a BOTTLE

NDC: 53002-7490-2 20 TABLET in a BOTTLE

NDC: 53002-7490-3 30 TABLET in a BOTTLE

Loratadine 10mg Tablets

INGREDIENTS AND APPEARANCE

LORATADINE ALLERGY RELIEF 
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53002-7490(NDC:51660-526)
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
STARCH, CORN (UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white (White to Off White)	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	RX526
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53002-7490-9	5 in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2018
2	NDC: 53002-7490-1	10 in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2018
3	NDC: 53002-7490-5	15 in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2018
4	NDC: 53002-7490-2	20 in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2018
5	NDC: 53002-7490-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076134	11/01/2017

Labeler - RPK Pharmaceuticals, Inc. (147096275)

Establishment
Name	Address	ID/FEI	Business Operations
RPK Pharmaceuticals, Inc.		147096275	RELABEL(53002-7490) , REPACK(53002-7490)