Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE SUN PHARMACEUTICAL INDUSTRIES, 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
ANDA090922

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients Cetirizine HCl USP 5 mg Pseudoephedrine HCl USP 120 mg
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 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 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: 915

Identifiers & Packaging

Container Type BOX
UNII
64O047KTOA 6V9V2RYJ8N
Packaging

Principal Display Panel - Showbox NDC 62756-915-62 Original Prescription Strength Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-release Tablets, USP 5 mg/120 mg Antihistamine/Nasal Decongestant Indoor & Outdoor Allergies ALLERGY & SINUS SUN PHARMA Actual Size DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN 12 Tablets (2 blister cards of 6 tablets each) 13; Principal Display Panel - Blister pack Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablet, USP 5 mg/120 mg Mfg. by: Sun Pharmaceutical Ind. Ltd. India. spl-cetirizine-pseudoephedrine-blister

Package Descriptions
  • Principal Display Panel - Showbox NDC 62756-915-62 Original Prescription Strength Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-release Tablets, USP 5 mg/120 mg Antihistamine/Nasal Decongestant Indoor & Outdoor Allergies ALLERGY & SINUS SUN PHARMA Actual Size DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN 12 Tablets (2 blister cards of 6 tablets each) 13
  • Principal Display Panel - Blister pack Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablet, USP 5 mg/120 mg Mfg. by: Sun Pharmaceutical Ind. Ltd. India. spl-cetirizine-pseudoephedrine-blister

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
Purpose

Purposes 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) (cer tain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks af ter 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 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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