LORATADINE- loratadine tablet 
Ohm Laboratories Inc.

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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 (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

INACTIVE INGREDIENTS

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

QUESTIONS?

Call 1-800-406-7984

PRINCIPAL DISPLAY PANEL

SOUND BODY

COMPARE TO THE ACTIVE INGREDIENT IN CLARITIN®†

Relief of: Sneezing, Itchy, Watery Eyes; Runny Nose; Itchy Throat or Nose

*When taken as directed. See Drug Facts Panel.

Original Prescription Strength

NON-DROWSY*

Allergy Relief

Loratadine Tablets, USP 10 mg

Antihistamine

Indoor & Outdoor Allergies

10 Tablets

24 HOURS

ALLERGY RELIEF

Manufactured by: Ohm Laboratories Inc.

5104668/R0713

carton
LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51660-209
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 RX;526
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51660-209-691 in 1 CARTON
110 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07613406/23/2009
Labeler - Ohm Laboratories Inc. (184769029)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.051565745manufacture(51660-209)

Revised: 9/2013
Document Id: 79cfee1c-0ae1-40dd-92d8-cb55dff96545
Set id: 6e22813e-d8e7-4a91-b510-50fc3f028933
Version: 1
Effective Time: 20130918
 
Ohm Laboratories Inc.