Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, USP

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Cetirizine HCl, USP 5 mg Pseudoephedrine HCl, USP 120 mg

Purposes

OTC - PURPOSE SECTION

Antihistamine Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking tranquilizers or sedatives.

When using this product

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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:

OTC - PREGNANCY OR BREAST FEEDING SECTION

if breast-feeding: not recommended if pregnant: ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

Call toll free 1-800-818-4555 weekdays

Principal Display Panel - Showbox

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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)

Principal Display Panel - Blister pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablet, USP 5 mg/120 mg Mfg. by: Sun Pharmaceutical Ind. Ltd. India.