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Name:Allergy Relief D
Manufacturer:Publix Super Markets Inc
Category:Over-the-counter (OTC) Marketed Drugs


Publix Allergy Relief D Drug Facts

ALLERGY RELIEF D - cetirizine hydrochloride and pseudoephedrine hydrochloride tablet, extended release 
Publix Super Markets Inc

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Publix Allergy Relief D Drug Facts

Active ingredient (in each extended release tablet)

Cetirizine HCl 5 mg

Pseudoephedrine HCl 120 mg

Purpose

Antihistamine

Nasal Decongestant

Uses

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
  • nasal congestion
  • 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 or to an antihistamine containing hydroxyzine.
  • 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
  • diabetes
  • glaucoma
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • liver or kidney disease. Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you are

taking tranquilizers or sedatives.

When using this product

  • do not use more than directed
  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • an allergic reaction to this product occurs. Seek medical help right away.
  • you get nervous, dizzy, or sleepless
  • symptoms do not improve within 7 days or are accompanied by fever

If pregnant or breast-feeding:

  • if breast-feeding: not recommended
  • if pregnant: 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 break or chew tablet; swallow tablet whole
adults and children 12 years and over take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours.
adults 65 years and over ask a doctor
children under 12 years of age ask a doctor
consumers with liver or kidney disease ask a doctor

Other information

  • store between 20° to 25°C (68° to 77°F)

Inactive ingredients

colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, yellow iron oxide

Principal Display Panel

Indoor & Outdoor Allergies

Allergy Relief D

Cetirizine Hydrochloride and

Pseudoephedrine Hydrochloride

Extended Release Tablets,

5 mg/120 mg

Antihistamine/Nasal Decongestant

Allergy & Congestion

12 Hour Relief of:

Sneezing

Itchy, Watery Eyes

Runny Nose

Itchy Throat or Nose

Nasal Congestion

Sinus Pressure

Actual Size

Extended Release Tablets

Compare to the Active Ingredients in Zyrtec-D®

Allergy Relief D Carton Image

Allergy Relief D Carton


ALLERGY RELIEF D 
cetirizine hcl, pseudoephedrine hcl tablet, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:56062-176
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE 5 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg
Inactive Ingredients
Ingredient Name Strength
COLLOIDAL SILICON DIOXIDE  
HYDROXYPROPYL CELLULOSE  
HYPROMELLOSES  
LACTOSE MONOHYDRATE  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
TALC  
FERRIC OXIDE YELLOW  
Product Characteristics
Color WHITE (one side white one side light yellow) Score no score
Shape ROUND Size 12mm
Flavor Imprint Code 5029;5;120
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:56062-176-53 2 BLISTER PACK ( BLISTER PACK) in 1 CARTON contains a BLISTER PACK
1 6 TABLET, EXTENDED RELEASE ( TABLET) in 1 BLISTER PACK This package is contained within the CARTON (56062-176-53)
2 NDC:56062-176-62 4 BLISTER PACK ( BLISTER) in 1 CARTON contains a BLISTER PACK
2 6 TABLET, EXTENDED RELEASE ( TABLET) in 1 BLISTER PACK This package is contained within the CARTON (56062-176-62)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077170 03/11/2010

Labeler - Publix Super Markets Inc (006922009)

Revised: 03/2010 Publix Super Markets Inc



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


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