ALLERGY AND CONGESTION RELIEF- loratadine and pseudoephedrine sulfate tablet, extended release 
Kroger Company

----------

Kroger Co. Allergy & Congestion Relief Drug Facts

Active ingredients (in each tablet)

Loratadine 5 mg  

Pseudoephedrine sulfate 120 mg

Purpose

Antihistamine

Nasal decongestant

Uses

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • sneezing
  • itchy, watery eyes
  • runny nose
  • itching of the nose or throat
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • reduces swelling of nasal passages
  • temporarily relieves sinus congestion and pressure
  • temporarily restores freer breathing through the nose

Warnings

Do not use

  • if you have ever had an allergic reaction to this product or any of its ingredients
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • heart disease
  • thyroid disease
  • high blood pressure
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • 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.
  • symptoms do not improve within 7 days or are accompanied by a fever
  • nervousness, dizziness or sleeplessness occurs

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

  • do not divide, crush, chew or dissolve the tablet
adults and children 12 years and over 1 tablet every 12 hours; not more than 2 tablets in 24 hours
children under 12 years of ageask a doctor

consumers with liver or

kidney disease		ask a doctor

Other information 

  • each tablet contains: calcium 25 mg
  • do not use if blister unit is broken or torn
  • store between 20° to 25°C (68° to 77°F)
  • keep in a dry place

Inactive ingredients

croscarmellose sodium, dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium stearate, pharmaceutical ink, povidone, titanium dioxide

Question or comments?

1-800-632-6900

Package/Label Principal Display Panel

COMPARE TO active ingredients of CLARITIN-D® 12 HOUR EXTENDED RELEASE TABLETS

See bottom panel

12 Hour

Non-Drowsy*

*When taken as directed.

See Drug Facts Panel.

Original Prescription Strength

Allergy & Congestion Relief

Pseudoephedrine Sulfate 120 mg/Loratadine 5 mg

Extended Release Tablets

Nasal Decongestant/Antihistamine

Indoor & Outdoor Allergies

Relief of:

Nasal and Sinus Congestion Due to Colds or Allergies

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose Due to Allergies

Actual Size

Allergy & Congestion Relief Carton Image 1

Allergy & Congestion Relief Carton Image 1

Allergy & Congestion Relief Carton Image 2

Allergy & Congestion Relief Carton Image 2

ALLERGY AND CONGESTION RELIEF 
loratadine, pseudoephedrine tablet, extended release
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:30142-013
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (LORATADINE) LORATADINE5 mg
PSEUDOEPHEDRINE SULFATE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE SULFATE120 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
HYPROMELLOSES 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
POVIDONE 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize12mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-013-393 in 1 CARTON
110 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07605004/06/2012
Labeler - Kroger Company (006999528)

Revised: 8/2012
Document Id: 331b1f38-37f4-46d7-a134-9bf3db9caaec
Set id: 331b1f38-37f4-46d7-a134-9bf3db9caaec
Version: 1
Effective Time: 20120810
 
Kroger Company