Your browser does not support JavaScript! GOOD SENSE ALLERGY AND CONGESTION RELIEF (PSEUDOEPHEDRINE SULFATE, LORATADINE) TABLET, FILM COATED [L PERRIGO COMPANY]
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GOOD SENSE ALLERGY AND CONGESTION RELIEF (pseudoephedrine sulfate, loratadine) tablet, film coated
[L Perrigo Company]


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

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 ageask a doctor
consumers with liver or kidney diseaseask 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, {and} titanium dioxide

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Non-Drowsy*

Original Prescription Strength

*When taken as directed. See Drug Facts Panel.

Allergy & Congestion Relief

Pseudoephedrine Sulfate 240 mg/Nasal Decongestant

Loratadine 10 mg/Antihistamine

Extended Release Tablets

Actual Size

24 hour

Relief of:

Nasal & Sinus Congestion Due to Colds or Allergies

Sneezing; Runny Nose; Itchy, Watery Eyes;

Itchy Throat or Nose Due to Allergies

Compare to active ingredients of Claritin-D® 24 Hour Tablets

Allergy & Congestion Relief Carton Image 1

Allergy & Congestion Relief Carton Image 1

Allergy & Congestion Relief Carton Image 2

Allergy & Congestion Relief Carton Image 2

GOOD SENSE ALLERGY AND CONGESTION RELIEF 
pseudoephedrine sulfate, loratadine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0113-0165
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 GLYCOL 
POLYETHYLENE GLYCOL 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITE (Off-White) Scoreno score
ShapeOVALSize18mm
FlavorImprint Code L724
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0113-0165-522 in 1 CARTON
15 in 1 BLISTER PACK
2NDC:0113-0165-223 in 1 CARTON
25 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07598906/22/2009
Labeler - L Perrigo Company (006013346)

Revised: 1/2011
 
L Perrigo Company

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