LORATADINE- loratadine tablet 
REMEDYREPACK INC.

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Drug Facts

Active ingredient (in each tablet)

Loratadine, USP 10

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 thisproduct 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)
  • do not use if seal under bottle cap is broken or missing
  • protect from excessive moisture

Inactive ingredients

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

Questions or comments? 

Call 1-800-706-5575, weekdays, 8:30am - 5:00pm Eastern Standard Time

DRUG: LORATADINE

GENERIC: Loratadine

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-1262-0

NDC: 70518-1262-1

COLOR: white

SHAPE: OVAL

SCORE: No score

SIZE: 8 mm

IMPRINT: LOR;10;APO

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 7 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • LORATADINE 10mg in 1

INACTIVE INGREDIENT(S):

  • LACTOSE MONOHYDRATE
  • MAGNESIUM STEARATE
  • MICROCRYSTALLINE CELLULOSE
  • CROSCARMELLOSE SODIUM
  • SILICON DIOXIDE

Remedy_Label

MM2

LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-1262(NDC:0536-1092)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize8mm
FlavorImprint Code LOR;10;APO
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70518-1262-030 in 1 BLISTER PACK; Type 0: Not a Combination Product06/18/201804/16/2020
2NDC:70518-1262-17 in 1 BLISTER PACK; Type 0: Not a Combination Product06/18/201804/16/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07647106/18/201804/16/2020
Labeler - REMEDYREPACK INC. (829572556)

Revised: 4/2020
Document Id: a36f69cc-a296-f5f2-e053-2a95a90a778b
Set id: 16c62b43-d632-4f50-a5c6-5411b8076920
Version: 4
Effective Time: 20200416
 
REMEDYREPACK INC.