DOSAGE & ADMINISTRATION SECTION.

DIRECTIONS. do not divide, crush, chew or dissolve the tabletadults and children 12 years and over1 tablet daily with full glass of water; not more than tablet in 24 hourschildren under 12 years of ageask doctorconsumers with liver or kidney diseaseask doctor. do not divide, crush, chew or dissolve the tablet.

INACTIVE INGREDIENT SECTION.

INACTIVE INGREDIENTS. calcium carbonate, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, sodium alginate, sodium citrate, talc and titanium dioxide.

INDICATIONS & USAGE SECTION.

USES. temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:sneezingitchy, watery eyesrunny noseitching of the nose or throat reduces swelling of nasal passagestemporarily relieves sinus congestion and pressuretemporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergiestemporarily restores freer breathing through the nose. temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:sneezingitchy, watery eyesrunny noseitching of the nose or throat sneezing. itchy, watery eyes. runny nose. itching of the nose or throat. reduces swelling of nasal passages. temporarily relieves sinus congestion and pressure. temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies. temporarily restores freer breathing through the nose.

OTC - ACTIVE INGREDIENT SECTION.

ACTIVE INGREDIENTS (IN EACH TABLET). Loratadine, USP 10 mgPseudoephedrine sulfate, USP 240 mg.

OTC - ASK DOCTOR SECTION.

Ask doctor before use if you have. heart diseasethyroid diseasehigh blood pressurediabetestrouble urinating due to an enlarged prostate glandliver or kidney disease. Your doctor should determine if you need different dose.. heart disease. thyroid disease. high blood pressure. diabetes. trouble urinating due to an enlarged prostate gland. liver or kidney disease. Your doctor should determine if you need different dose.

OTC - DO NOT USE SECTION.

Do not use. if you have ever had an allergic reaction to this product or any of its ingredientsif you are now taking prescription monoamine oxidase 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.. if you have ever had an allergic reaction to this product or any of its ingredients. if you are now taking prescription monoamine oxidase 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.

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 (1-800-222-1222).

OTC - PREGNANCY OR BREAST FEEDING SECTION.

If pregnant or breast-feeding,. ask health professional before use.

OTC - PURPOSE SECTION.

PURPOSE. AntihistamineNasal decongestant.

OTC - QUESTIONS SECTION.

QUESTIONS. call 1-800-406-7984 Keep the carton. It contains important information.See end panel for expiration date.

OTC - STOP USE SECTION.

Stop use and ask doctor if. an allergic reaction to this product occurs. Seek medical help right away.symptoms do not improve within days or are accompanied by fevernervousness, dizziness or sleeplessness occurs. an allergic reaction to this product occurs. Seek medical help right away.. symptoms do not improve within days or are accompanied by fever. nervousness, dizziness or sleeplessness occurs.

OTC - WHEN USING SECTION.

When using this product do not take more than directed.. Taking more than directed may cause drowsiness.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL 240 mg/10 mg Tablet Blister Pack Carton. MAJOR(R) NDC 0904-5833-15Compare to active ingredients ofClaritin-D(R) 24 HourOriginal Prescription StrengthNon-DrowsyLoratadineoDExtended-ReleaseTabletsPseudoephedrine Sulfate, USP 240 mg/Nasal DecongestantLoratadine, USP 10 mg/AntihistamineIndoor Outdoor AllergiesAllergy Congestion24HOURRelief of:Nasal and Sinus Congestion Due to Colds or AllergiesSneezing; Runny Nose; Itchy, Watery Eyes;Itchy Throat or Nose Due to AllergiesWhen taken as directed. See Drug Facts Panel.10Extended-ReleaseTablets. PRINCIPAL DISPLAY PANEL 240 mg/10 mg Tablet Blister Pack Carton.

SPL UNCLASSIFIED SECTION.

OTHER INFORMATION. sodium: contains 10 mg/tabletcalcium: contains 25 mg/tabletTAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE. (for bottle cartons/labels only)TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. (for blister cartons only)store between 20 to 25 (68 to 77 F).protect from light and store in dry place. sodium: contains 10 mg/tablet. calcium: contains 25 mg/tablet. TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE. (for bottle cartons/labels only). TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. (for blister cartons only). store between 20 to 25 (68 to 77 F).. protect from light and store in dry place.

WARNINGS SECTION.

WARNINGS. Do not use. if you have ever had an allergic reaction to this product or any of its ingredientsif you are now taking prescription monoamine oxidase 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.. if you have ever had an allergic reaction to this product or any of its ingredients. if you are now taking prescription monoamine oxidase 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.. Ask doctor before use if you have. heart diseasethyroid diseasehigh blood pressurediabetestrouble urinating due to an enlarged prostate glandliver or kidney disease. Your doctor should determine if you need different dose.. heart disease. thyroid disease. high blood pressure. diabetes. trouble urinating due to an enlarged prostate gland. liver or kidney disease. Your doctor should determine if you need different dose.. When using this product do not take more than directed.. Taking more than directed may cause drowsiness.. Stop use and ask doctor if. an allergic reaction to this product occurs. Seek medical help right away.symptoms do not improve within days or are accompanied by fevernervousness, dizziness or sleeplessness occurs. an allergic reaction to this product occurs. Seek medical help right away.. symptoms do not improve within days or are accompanied by fever. nervousness, dizziness or sleeplessness occurs. If pregnant or breast-feeding,. ask health professional before use.. Keep out of reach of children.. In case of overdose, get medical help or contact Poison Control Center right away (1-800-222-1222).