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Name:Allergy And Congestion Relief
Manufacturer:Hannaford Brothers Company
Category:Over-the-counter (OTC) Marketed Drugs


Hannaford Bros. Co. Allergy and Congestion Relief Drug Facts

ALLERGY AND CONGESTION RELIEF - loratadine and pseudoephedrine sulfate tablet, film coated 
Hannaford Brothers Company

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Hannaford Bros. Co. Allergy and Congestion Relief Drug Facts

Active ingredient (in each tablet)

Loratadine 10 mg

Pseudoephedrine sulfate 240 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.

Directions

  • do not divide, crush, chew or dissolve the tablet
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 age ask a doctor
consumers with liver or kidney disease ask a doctor

Other information

  • store between 20ºC to 25ºC (68ºF to 77ºF)
  • protect from light and store in a dry place

Inactive ingredients

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

Questions or comments?

1-800-213-9040

Package/Label Principal Display Panel

Compare to Claritin-D® 24 Hour active ingredients

24 hour

Non-Drowsy*

Allergy & Congestion Relief

Pseudoephedrine Sulfate 240 mg/Nasal Decongestant

Loratadine 10 mg/Antihistamine

Extended Release Tablets

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

Original Prescription Strength

*When taken as directed. See Drug Facts Panel.

Allergy and Congestion Relief Carton Image 1

Allergy and Congestion Relief Carton Image 1

Allergy and Congestion Relief Carton Image 2

Allergy and Congestion Relief Carton Image 2


ALLERGY AND CONGESTION RELIEF 
pseudoephedrine sulfate, loratadine tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41268-165
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LORATADINE (LORATADINE) LORATADINE 10 mg
PSEUDOEPHEDRINE SULFATE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE SULFATE 240 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES  
MAGNESIUM STEARATE  
POLYETHYLENE GLYCOL  
POLYETHYLENE GLYCOL  
TITANIUM DIOXIDE  
Product Characteristics
Color WHITE (Off-White) Score no score
Shape OVAL Size 18mm
Flavor Imprint Code L724
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:41268-165-52 2 BLISTER PACK ( BLISTER PACK) in 1 CARTON contains a BLISTER PACK
1 5 TABLET, FILM COATED ( TABLET) in 1 BLISTER PACK This package is contained within the CARTON (41268-165-52)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075989 06/03/2009

Labeler - Hannaford Brothers Company (006949556)

Revised: 01/2011 Hannaford Brothers Company



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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