LORATADINE- loratadine tablet 
Valu Merchandisers Company

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Drug Facts

ACTIVE INGREDIENT (IN EACH TABLET)

Loratadine USP, 10 mg

PURPOSE

Antihistamine

USES

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

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

INACTIVE INGREDIENTS

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

QUESTIONS?

Call 1-800-406-7984

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Blister Pack Carton

COMPARE TO THE ACTIVE INGREDIENT IN CLARITIN®*

Best
Choice®

Non-Drowsy†

ORIGINAL PRESCRIPTION STRENGTH
ALLERGY RELIEF

Loratadine Tablets, USP 10 mg
ANTIHISTAMINE

24 Hour Allergy Relief
Indoor & Outdoor Allergies

Relief of:

10 TABLETS

† When taken as directed. See Drug Facts Panel.

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Blister Pack Carton
LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-526
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
Colorwhite (White to Off-White) Scoreno score
ShapeROUNDSize6mm
FlavorImprint Code RX526
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63941-526-6910 in 1 BLISTER PACK; Type 0: Not a Combination Product08/19/2003
2NDC:63941-526-3130 in 1 BLISTER PACK; Type 0: Not a Combination Product08/19/2003
3NDC:63941-526-6060 in 1 BOTTLE; Type 0: Not a Combination Product08/19/2003
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07613408/19/2003
Labeler - Valu Merchandisers Company (868703513)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.051565745manufacture(63941-526)

Revised: 8/2018
Document Id: bc05aca7-4224-4b42-93b7-d28fbf18c0b1
Set id: 0cd920b4-b15a-4ca9-87e2-4dd523c6d1f8
Version: 2
Effective Time: 20180828
 
Valu Merchandisers Company