Perrigo Loratadine Tablets, 10 mg Drug Facts

Drug Details [pdf]

LORATADINE ANTIHISTAMINE- loratadine tablet
Unit Dose Services

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Perrigo Loratadine Tablets, 10 mg 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. (1-800-222-1222)

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

do not use if printed foil under cap is broken or missing
store between 20° to 25°C (68° to 77°F)

Inactive ingredients

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

Questions or comments?

1-800-719-9260

HOW SUPPLIED

Product: 50436-3502

LORATADINE ANTIHISTAMINE (LORATADINE) TABLET

LORATADINE ANTIHISTAMINE
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50436-3502(NDC: 45802-650)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg

Ingredient Name	Strength
Inactive Ingredients
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	8mm
Flavor		Imprint Code	L612
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 50436-3502-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	10/15/2008	12/31/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076301	10/15/2008	12/31/2017

Labeler - Unit Dose Services (831995316)

Name	Address	ID/FEI	Business Operations
Establishment
Unit Dose Services		831995316	REPACK(50436-3502) , RELABEL(50436-3502)

Revised: 5/2019

Document Id: 1eb84efe-e51e-4dc6-81d3-f4420b3fba64

Set id: eafdf607-0428-409f-be01-25966a0c2d1b

Version: 6

Effective Time: 20190502