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Loratadine ODT by Safeway Inc.

Medically reviewed on Sep 25, 2018

Dosage form: tablet, orally disintegrating
Ingredients: LORATADINE 10mg
Labeler: Safeway Inc.
NDC Code: 21130-527

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 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
  • 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, fruit flavors, magnesium stearate, mannitol, sodium stearyl fumarate

QUESTIONS OR COMMENTS?

Call 1-888-SAFEWAY

PRINCIPAL DISPLAY PANEL

NDC 21130-527-69

Compare to Claritin®RediTabs®active ingredient

Original Prescription Strength

Non-Drowsy*

24-Hour Allergy Relief

Loratadine Orally Disintegrating Tablets, 10 mg

Antihistamine

Indoor & Outdoor Allergies

  • No Water Needed
  • Melts in Your Mouth

Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

For Adults and Children Six Years and Older

*When taken as directed.

See Drug Facts Panel.

10 ORALLY DISINTEGRATING TABLETS

SAFEWAY

DISTRIBUTED BY SAFEWAY INC.

5082800/R0212

LORATADINE ODT 
loratadine tablet, orally disintegrating
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-527
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 faced beveled edge) Size10mm
FlavorFRUITImprint CodeRC17
Contains    
Packaging
#Item CodePackage Description
1NDC:21130-527-6910 TABLET, ORALLY DISINTEGRATING (TABLET) in 1 BLISTER PACK
2NDC:21130-527-3130 TABLET, ORALLY DISINTEGRATING (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07715308/31/2007
Labeler - Safeway Inc. (009137209)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIOperations
Ohm Laboratories Inc.051565745manufacture(21130-527)

 
Safeway Inc.

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Further information

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

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