LORATADINE- loratadine tablet, orally disintegrating 
Supervalu 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

Aspartame, croscarmellose sodium, magnesium stearate, mannitol, mint flavor, sodium stearyl fumarate, strawberry cream flavor, tutti-frutti flavor

QUESTIONS?

Call 1-877-932-7948

PRINCIPAL DISPLAY PANEL

equaline®

compare to Claritin®RediTabs®active ingredient**

NDC 41163-528-69

original prescription strength

melts in your mouth

allergy relief

loratadine orally disintegrating tablets, USP 10 mg

antihistamine

no water needed

indoor and outdoor allergies

non-drowsy* 24 hour relief of:

10 orally disintegrating tablets

*When taken as directed. See Drug Facts Panel.

DISTRIBUTED BY SUPERVALU INC.

5105058/ R0913

equalinelabel
LORATADINE 
loratadine tablet, orally disintegrating
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-528
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME (UNII: Z0H242BBR1)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
Product Characteristics
Colorwhite (White to Off-White) Scoreno score
ShapeROUND (flat face, beveled edged) Size10mm
FlavorSTRAWBERRY, TUTTI FRUTTI, MINTImprint Code RC17
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41163-528-691 in 1 CARTON
110 in 1 BLISTER PACK
2NDC:41163-528-313 in 1 CARTON
210 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07715312/03/2013
Labeler - Supervalu Inc. (006961411)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.051565745manufacture(41163-528)

Revised: 12/2013
Document Id: 35af7285-9558-4f37-a826-594676f46763
Set id: bc253aa7-686c-40e6-affa-a585b465046a
Version: 1
Effective Time: 20131204
 
Supervalu Inc.