Allergy relief-D CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE RITE AID FDA Approved Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of 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
ANDA090922

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each extended-release tablet) Purposes Cetirizine HCl USP 5 mg Antihistamine Pseudoephedrine HCl USP 120 mg Nasal Decongestant
Inactive Ingredients
Inactive ingredients hydroxyethyl cellulose hydroxypropyl cellulose hypromellose magnesium stearate microcrystalline cellulose stearic acid titanium dioxide Imprinting Ink Contents: ammonium hydroxide iron oxide black isopropyl alcohol N-butyl alcohol propylene glycol shellac glaze
Strengths
5 mg 120 mg
Quantities
12 tablet 12 tablets 6 tablets
Treats Conditions
Uses Temporarily Relieves These Symptoms Due To Hay Fever Or Other Upper Respiratory Allergies Runny Nose Sneezing Itchy Watery Eyes Itching Of 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: 915

Identifiers & Packaging

Container Type BOX
UNII
64O047KTOA 6V9V2RYJ8N
Packaging

PRINCIPAL DISPLAY PANEL - 12 Tablet Blister Card Carton NDC 11822-9994-1 12 HOUR Compare to the active ingredient of Zyrtec-D ® 12hr* ORIGINAL PRESCRIPTION STRENGTH ALLERGY RELIEF NASAL DECONGESTANT CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, USP 5 mg/120 mg ANTIHISTAMINE/NASAL DECONGESTANT INDOOR & OUTDOOR ALLERGIES ALLERGY & SINUS 12 HOUR RELIEF OF Sneezing • Runny nose • Nasal congestion Itchy, watery eyes • Sinus pressure Itchy throat or nose ACTUAL SIZE 12 TABLETS (2 blister cards of 6 tablets each) carton image

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - 12 Tablet Blister Card Carton NDC 11822-9994-1 12 HOUR Compare to the active ingredient of Zyrtec-D ® 12hr* ORIGINAL PRESCRIPTION STRENGTH ALLERGY RELIEF NASAL DECONGESTANT CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, USP 5 mg/120 mg ANTIHISTAMINE/NASAL DECONGESTANT INDOOR & OUTDOOR ALLERGIES ALLERGY & SINUS 12 HOUR RELIEF OF Sneezing • Runny nose • Nasal congestion Itchy, watery eyes • Sinus pressure Itchy throat or nose ACTUAL SIZE 12 TABLETS (2 blister cards of 6 tablets each) carton image

Overview

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of 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 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 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 at 1-800-222-1222.
Purpose

Active ingredients (in each extended-release tablet) Purposes Cetirizine HCl, USP 5 mg Antihistamine Pseudoephedrine HCl, USP 120 mg 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 at 1-800-222-1222.

Storage & Handling

Other information store between 20° to 25°C (68° to 77°F) do not use if carton is opened or if the blister unit is broken see side panel for lot number and expiration date

Questions

Questions? call toll free 1-800-818-4555 weekdays


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