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Loratadine by Supervalu Inc.

Dosage form: tablet, orally disintegrating
Ingredients: LORATADINE 10mg
Labeler: Supervalu Inc.
NDC Code: 41163-528

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:

  • 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
  • place 1 tablet on tongue; tablet disintegrates, with or without water
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
  • Phenylketonurics: Contains Phenylalanine 0.6 mg Per Tablet.
  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • store between 20° to 25° C (68° to 77° F). Protect from excessive moisture.
  • keep in a dry place.
  • use tablet immediately after opening individual blister.

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:

  • runny nose
  • itchy, watery eyes
  • sneezing
  • itchy throat or nose

10 orally disintegrating tablets

*When taken as directed. See Drug Facts Panel.

DISTRIBUTED BY SUPERVALU INC.

5105058/ R0913

LORATADINE 
loratadine tablet, orally disintegrating
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-528
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (LORATADINE) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME 
CROSCARMELLOSE SODIUM 
MAGNESIUM STEARATE 
MANNITOL 
SODIUM STEARYL FUMARATE 
Product Characteristics
Colorwhite (White to Off-White) Scoreno score
ShapeROUND (flat face, beveled edged) Size10mm
FlavorSTRAWBERRY, TUTTI FRUTTI, MINTImprint CodeRC17
Contains    
Packaging
#Item CodePackage Description
1NDC:41163-528-691 BLISTER PACK (BLISTER PACK) in 1 CARTON
110 TABLET, ORALLY DISINTEGRATING (TABLET) in 1 BLISTER PACK
2NDC:41163-528-313 BLISTER PACK (BLISTER PACK) in 1 CARTON
210 TABLET, ORALLY DISINTEGRATING (TABLET) 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/FEIOperations
Ohm Laboratories Inc.051565745manufacture(41163-528)

 
Supervalu Inc.

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Medically reviewed on Dec 4, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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