Your browser does not support JavaScript! LORATADINE ODT (LORATADINE) TABLET, ORALLY DISINTEGRATING [SAFEWAY INC.]
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LORATADINE ODT (loratadine) tablet, orally disintegrating
[Safeway Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

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

This is the 10 count blister carton label for Safeway Loratadine ODT.

LORATADINE ODT 
loratadine tablet, orally disintegrating
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 Code RC17
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-527-6910 in 1 BLISTER PACK
2NDC:21130-527-3130 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/FEIBusiness Operations
Ohm Laboratories Inc.051565745manufacture(21130-527)

Revised: 9/2012
 
Safeway Inc.

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