DOSAGE & ADMINISTRATION SECTION.

DIRECTIONS. adults and children 12 years and over: tablet every 12 hours. Do not exceed tablets in 24 hours.children under 12 years of age: ask doctor. adults and children 12 years and over: tablet every 12 hours. Do not exceed tablets in 24 hours.. children under 12 years of age: ask doctor. OTHER INFORMATION. each tablet contains: calcium 69 mg and sodium mgstore between 20 to 25C (68 to 77F)protect from excessive moisture. each tablet contains: calcium 69 mg and sodium mg. store between 20 to 25C (68 to 77F). protect from excessive moisture.

INACTIVE INGREDIENT SECTION.

INACTIVE INGREDIENTS. calcium sulfate, carnauba wax, colloidal silicon dioxide, D&C yellow No. 10 aluminum lake, FD&C blue No. aluminum lake, FD&C yellow No. aluminum lake, gelatin, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, methyl parahydroxybenzoate, microcrystalline cellulose, pharmaceutical ink, polysorbate 80, povidone, pregelatinized maize starch, propyl parahydroxy benzoate, sodium benzoate, sodium lauryl sulfate, sucrose, talc, titanium dioxide, triethyl citrateQUESTIONScall 1-215-579-1842 PRODUCT PACKAGING. The product packaging shown below represents sample of that currently in use. Additional packaging may also be available.Dexbrompheniramine Maleate mgand Pseudoephedrine Sulfate 120 mgExtended-release TabletsAntihistamine/Nasal DecongestantCOLD ALLERGYMaximum StrengthNasal Sinus CongestionRunny Nose, SneezingItchy, Watery Eyes12 Hour Sustained Relief 20 EXTENDED-RELEASE TABLETS SAFETY SEALED: DO NOT USE IF BACKING ON BLISTER CARD IMPRINTED WITH DEXBROMPHENIRAMINE MALEATE mg AND PSEUDOEPHEDRINE SULFATE 120 mg IS TORN OR MISSING. Manufactured by KVK-TECH, INC. Newtown, PA18940 MADE IN USA Nasal Sinus Congestion. Runny Nose, Sneezing. Itchy, Watery Eyes12 Hour Sustained Relief 20 EXTENDED-RELEASE TABLETS SAFETY SEALED: DO NOT USE IF BACKING ON BLISTER CARD IMPRINTED WITH DEXBROMPHENIRAMINE MALEATE mg AND PSEUDOEPHEDRINE SULFATE 120 mg IS TORN OR MISSING. Manufactured by KVK-TECH, INC. Newtown, PA18940 MADE IN USA.

INDICATIONS & USAGE SECTION.

WHEN USING THIS PRODUCT. do not use more than directedexcitability may occur, especially in childrendrowsiness may occuravoid alcoholic beveragesalcohol, sedatives, and tranquilizers may increase drowsinessuse caution when driving motor vehicle or operating machinery. do not use more than directed. excitability may occur, especially in children. drowsiness may occur. avoid alcoholic beverages. alcohol, sedatives, and tranquilizers may increase drowsiness. use caution when driving motor vehicle or operating machinery.

OTC - ACTIVE INGREDIENT SECTION.

ACTIVE INGREDIENT (IN EACH TABLET). Dexbrompheniramine maleate mgPseudoephedrine Sulfate 120 mg.

OTC - ASK DOCTOR SECTION.

ASK DOCTOR BEFORE USE IF YOU HAVE. breathing problem such as emphysema or chronic bronchitisglaucomaheart diseasehigh blood pressurethyroid diseasediabetestrouble urinating due to an enlarged prostate gland. breathing problem such as emphysema or chronic bronchitis. glaucoma. heart disease. high blood pressure. thyroid disease. diabetes. trouble urinating due to an enlarged prostate gland.

OTC - ASK DOCTOR/PHARMACIST SECTION.

ASK DOCTOR/PHARMACIST BEFORE USE IF YOU ARE. taking sedative or tranquilizers. taking sedative or tranquilizers.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION.

KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact Poison Control Center right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION.

IF PREGNANT OR BREAST-FEEDING. ask health professional before use.

OTC - PURPOSE SECTION.

PURPOSE. AntihistamineNasal decongestant. USES. temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, and associated with sinusitishelps decongest sinus openings and sinus passagesreduces swelling of nasal passages, shrinks swollen membranes, and temporarily restores freer breathing through the nosetemporarily alleviates the following symptoms due to hay fever (allergic rhinitis):runny nose sneezing itching of the nose or throat itchy and watery eyes temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, and associated with sinusitis. helps decongest sinus openings and sinus passages. reduces swelling of nasal passages, shrinks swollen membranes, and temporarily restores freer breathing through the nose. temporarily alleviates the following symptoms due to hay fever (allergic rhinitis):runny nose sneezing itching of the nose or throat itchy and watery eyes runny nose. sneezing. itching of the nose or throat. itchy and watery eyes.

OTC - STOP USE SECTION.

STOP USE AND ASK DOCTOR IF. nervousness, dizziness or sleeplessness occursymptoms do not improve within days or occur with feverYou may report side effects to FDA at 1-800-FDA 1088 nervousness, dizziness or sleeplessness occur. symptoms do not improve within days or occur with fever.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Principal Display Panel. Carton LabelDexbrompheniramine Maleate mgand Pseudoephedrine Sulfate 120 mgExtended-release TabletsAntihistamine/Nasal DecongestantCOLD ALLERGYMaximum StrengthNasal Sinus CongestionRunny Nose, SneezingItchy, Watery Eyes12 Hour Sustained Relief20 EXTENDED-RELEASE TABLETSContainer LabelNDC 10702-005-03Dexbrompheniramine Maleate mgand Pseudoephedrine Sulfate 120 mgExtended-release TabletsAntihistamine/Nasal DecongestantCOLD ALLERGYMaximum StrengthNasal Sinus Congestionunny Nose, SneezingItchy, Watery Eyes12 Hour Sustained Relief30 EXTENDED-RELEASE TABLETSDO NOT USE IF PRINTED FOIL UNDER CAP IS BROKEN OR MISSING.. Nasal Sinus Congestion. Runny Nose, Sneezing. Itchy, Watery Eyes12 Hour Sustained Relief. Nasal Sinus Congestionunny Nose, Sneezing. Itchy, Watery Eyes12 Hour Sustained Relief. carton label. container Label.

SPL UNCLASSIFIED SECTION.

DRUG FACTS.

WARNINGS SECTION.

WARNINGS. Do not use If you are now taking prescription monoamineoxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinsons disease), or for weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask doctor or pharmacist before taking this product.