allergy relief d CETIRIZINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE PUBLIX SUPER MARKETS INC FDA Approved 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
FunFoxMeds box
Route
ORAL
Applications
ANDA210719

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each extended release tablet) Cetirizine HCl 5 mg Pseudoephedrine HCl 120 mg
Inactive Ingredients
Inactive ingredients colloidal silicon dioxide hypromellose lactose monohydrate low-substituted hydroxypropyl cellulose magnesium stearate microcrystalline cellulose polyethylene glycol polyvinyl alcohol talc titanium dioxide
Strengths
5 mg 120 mg
Treats Conditions
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
Pill Appearance
Shape: round Color: white Imprint: L147

Identifiers & Packaging

Container Type BOX
UNII
64O047KTOA 6V9V2RYJ8N
Packaging

Package/Label Principal Display Panel p INDOOR + OUTDOOR ALLERGIES allergyreliefD CETIRIZINE HYDROCHLORIDE & PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 5 mg/120 mg ANTIHISTAMINE/NASAL DECONGESTANT 12 hour relief ALLERGY + SINUS NASAL CONGESTION + SINUS PRESSURE • Sneezing • Itchy, watery eyes • Runny nose • Itchy nose or throat ACTUAL SIZE 12 EXTENDED-RELEASE TABLETS ACTUAL SIZE *Compare to Zyrtec-D ® active ingredients publix-allergy-relief-d-carton-image.jpg

Package Descriptions
  • Package/Label Principal Display Panel p INDOOR + OUTDOOR ALLERGIES allergyreliefD CETIRIZINE HYDROCHLORIDE & PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 5 mg/120 mg ANTIHISTAMINE/NASAL DECONGESTANT 12 hour relief ALLERGY + SINUS NASAL CONGESTION + SINUS PRESSURE • Sneezing • Itchy, watery eyes • Runny nose • Itchy nose or throat ACTUAL SIZE 12 EXTENDED-RELEASE TABLETS ACTUAL SIZE *Compare to Zyrtec-D ® active ingredients publix-allergy-relief-d-carton-image.jpg

Overview

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

Indications & Usage

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

Dosage & Administration

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

Warnings & Precautions
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 pregnancy 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. (1-800-222-1222)
Purpose

Purpose Antihistamine Nasal decongestant

Do Not Use

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.

When Using

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 & Ask a Doctor

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

Keep Out of Reach of Children

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)

Storage & Handling

Other information • store between 68° to 77°F (20° to 25°C) • do not use if blister unit is broken or torn • see side panel for lot number and expiration date • meets USP Dissolution Test 2


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