LORATADINE ANTIHISTAMINE- loratadine tablet 
REMEDYREPACK INC.

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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

DRUG: Loratadineantihistamine antihistamine

GENERIC: Loratadine

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 49349-218-03

COLOR: white

SHAPE: OVAL

SCORE: No score

SIZE: 8 mm

IMPRINT: L612

PACKAGING: 20 in 1 BOTTLE

ACTIVE INGREDIENT(S):

  • LORATADINE 10mg in 1

INACTIVE INGREDIENT(S):

  • LACTOSE MONOHYDRATE
  • MAGNESIUM STEARATE
  • POVIDONES

Remedy_Label

LORATADINE ANTIHISTAMINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49349-218
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONES (UNII: FZ989GH94E)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize8mm
FlavorImprint Code L612
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49349-218-0320 in 1 BOTTLE; Type 0: Not a Combination Product10/13/201404/19/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07630110/13/201404/19/2016
Labeler - REMEDYREPACK INC. (829572556)

Revised: 10/2016
Document Id: 3eaf27ca-379a-1f0d-e054-00144ff88e88
Set id: 42387fa2-cb58-4917-a3e4-71dd96c238e7
Version: 2
Effective Time: 20161012
 
REMEDYREPACK INC.