Loratadine Tablet 10 mg

Drug Details [pdf]

LORATADINE- loratadine tablet
AvPAK

----------

Loratadine Tablet 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
sneezing
itchy, watery eyes
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 or kidney disease	ask a doctor

Other information

store between 2° and 30°C (36° and 86°F)
protect from exceesive moisture

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50268-488-15
Loratadine Tablets, USP
Non-Drowsy*
Antihistamine
10 mg
50 Tablets (5 X10) Unit Dose

5026848815

24 Hour Relief Of: Sneezing, Runny Nose, Itchy, Watery Eyes, Itchy Throat or Nose
*When taken as directed. See Drug Facts Panel.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478
Mfg. Rev. 03/05 AV 03/16 (P)

AvPAK
A PRODUCT OF AvKARE

LORATADINE
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50268-488(NDC: 60505-0147)
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	8mm
Flavor		Imprint Code	LOR;10;APO
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 50268-488-15	50 in 1 BOX, UNIT-DOSE	03/11/2016	09/30/2019
1	NDC: 50268-488-11	1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076471	03/11/2016	09/30/2019

Labeler - AvPAK (832926666)

Revised: 10/2019

Document Id: 93dc7087-f86a-3576-e053-2995a90a34d4

Set id: 6d8e16ad-dee7-690e-6862-29207e09fb81

Version: 3

Effective Time: 20191001