ALLERGY AND CONGESTION RELIEF NON DROWSY - loratadine and pseudoephedrine sulfate tablet, film coated 
Amerisource Bergen

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Active ingredient (in each tablet)

Loratadine 10 mg

Pseudoephedrine sulfate 240 mg

Purpose

Antihistamine

Nasal decongestant

Uses

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.

Directions

adults and children 12 years and over 1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours
children under 12 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other information

Inactive ingredients

colloidal silicon dioxide, hydrogenated vegetable oil, hypromellose, magnesium stearate, pharmaceutical ink, polyethylene glycol, polyethylene oxide,  titanium dioxide

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare To Active Ingredients In Claritin-D® 24 Hour

Non-Drowsy

# Days of Relief {replace "#" with number of tablets in carton}

Original Prescription Strength

Allergy & Congestion Relief

Pseudoephedrine Sulfate 240 mg/Nasal Decongestant

Loratadine 10 mg/Antihistamine

Extended Release Tablets

24 hour

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

*When taken as directed. See Drug Facts Panel.

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  NON DROWSY
pseudoephedrine sulfate, loratadine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24385-351
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (LORATADINE) LORATADINE10 mg
PSEUDOEPHEDRINE SULFATE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE SULFATE240 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOLS 
TITANIUM DIOXIDE 
SILICON DIOXIDE 
POLYETHYLENE GLYCOLS 
Product Characteristics
ColorWHITE (Off-White) Score no score
ShapeOVALSize18mm
FlavorImprint Code L724
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:24385-351-223 BLISTER PACK ( BLISTER PACK) in 1 CARTONcontains a BLISTER PACK
15 TABLET, FILM COATED ( TABLET) in 1 BLISTER PACKThis package is contained within the CARTON (24385-351-22)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07598911/13/2010

Labeler - Amerisource Bergen (007914906)

Revised: 01/2011 Amerisource Bergen