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Loratadine by AvPAK

Medically reviewed on May 31, 2018

Dosage form: tablet
Ingredients: LORATADINE 10mg
Labeler: AvPAK
NDC Code: 50268-488

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 over1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask 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

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:50268-488(NDC:60505-0147)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (LORATADINE) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize8mm
FlavorImprint CodeLOR;10;APO
Contains    
Packaging
#Item CodePackage Description
1NDC:50268-488-1550 BLISTER PACK in 1 BOX, UNIT-DOSE
1NDC:50268-488-111 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07647103/11/2016
Labeler - AvPAK (832926666)

 
AvPAK

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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