DOSAGE & ADMINISTRATION SECTION.


Directions. odo not take more than directedothe smallest effective dose should be usedoadults and children 12 years of age and over:otake caplet every to hours while symptoms persist. If symptoms do not respond to caplet, caplets may be used.odo not use more than caplets in any 24-hour period unless directed by doctorochildren under 12 years of age: do not use. odo not take more than directed. othe smallest effective dose should be used. oadults and children 12 years of age and over:otake caplet every to hours while symptoms persist. If symptoms do not respond to caplet, caplets may be used.odo not use more than caplets in any 24-hour period unless directed by doctor. otake caplet every to hours while symptoms persist. If symptoms do not respond to caplet, caplets may be used.. odo not use more than caplets in any 24-hour period unless directed by doctor. ochildren under 12 years of age: do not use.

INACTIVE INGREDIENT SECTION.


Inactive ingredients. acacia, calcium carbonate, carnauba wax, confectioners sugar, corn starch, croscarmellose sodium, crospovidone, FD&C Blue no. Aluminum Lake, FD&C Red no. 40 Aluminum Lake, FD&C Yellow no. Aluminum Lake, gelatin, guar gum, hydrogenated vegetable oil, hydroxypropyl cellulose, iron oxide black, kaolin, polyethylene glycol, powdered cellulose, povidone, pregelatinized starch, propylene glycol, shellac, silicon dioxide, sodium benzoate, sucrose, talc, titanium dioxide, white wax.

INDICATIONS & USAGE SECTION.


Uses. temporarily relieves these symptoms associated with the common cold or flu:oheadacheofeverosinus pressureonasal congestionominor body aches and pains. oheadache. ofever. osinus pressure. onasal congestion. ominor body aches and pains.

OTC - ACTIVE INGREDIENT SECTION.


Active ingredients (in each caplet)PurposesIbuprofen, USP 200 mg (NSAID)nonsteroidal anti-inflammatory drug Pain reliever/fever reducerPseudoephedrine HCl, USP 30 mgNasal decongestant.

OTC - ASK DOCTOR SECTION.


Ask doctor before use if. ostomach bleeding warning applies to youoyou have problems or serious side effects from taking pain relievers or fever reducersoyou have history of stomach problems, such as heartburnoyou have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland, or had strokeoyou are taking diuretic. ostomach bleeding warning applies to you. oyou have problems or serious side effects from taking pain relievers or fever reducers. oyou have history of stomach problems, such as heartburn. oyou have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland, or had stroke. oyou are taking diuretic.

OTC - ASK DOCTOR/PHARMACIST SECTION.


Ask doctor or pharmacist before use if you are. ounder doctors care for any serious conditionotaking any other product that contains pseudoephedrine or any other nasal decongestantotaking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirinotaking any other drug. ounder doctors care for any serious condition. otaking any other product that contains pseudoephedrine or any other nasal decongestant. otaking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin. otaking any other drug.

OTC - DO NOT USE SECTION.


Do not use. oin children under 12 years of ageoif you have ever had an allergic reaction to any other pain reliever/fever reduceroright before or after heart surgeryoif 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.. oin children under 12 years of age. oif you have ever had an allergic reaction to any other pain reliever/fever reducer. oright before or after heart surgery. oif 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. It is especially important not to use ibuprofen during the last months of pregnancy unless definitely directed to do so by doctor because it may cause problems in the unborn child or complications during delivery.

OTC - PURPOSE SECTION.


Active ingredients (in each caplet)PurposesIbuprofen, USP 200 mg (NSAID)nonsteroidal anti-inflammatory drug Pain reliever/fever reducerPseudoephedrine HCl, USP 30 mgNasal decongestant.

OTC - QUESTIONS SECTION.


Questions. call 1-800-406-7984.

OTC - STOP USE SECTION.


Stop use and ask doctor if. oyou experience any of the following signs of stomach bleeding:ofeel faintovomit bloodohave bloody or black stoolsohave stomach pain that does not get betteroyou have symptoms of heart problems or stroke:ochest painotrouble breathingoweakness in one part or side of bodyoslurred speecholeg swellingofever gets worse or lasts more than daysonasal congestion lasts for more than daysosymptoms continue or get worseoredness or swelling is present in the painful areaoyou get nervous, dizzy, or sleeplessoany new symptoms appear. oyou experience any of the following signs of stomach bleeding:ofeel faintovomit bloodohave bloody or black stoolsohave stomach pain that does not get better. ofeel faint. ovomit blood. ohave bloody or black stools. ohave stomach pain that does not get better. oyou have symptoms of heart problems or stroke:ochest painotrouble breathingoweakness in one part or side of bodyoslurred speecholeg swelling. ochest pain. otrouble breathing. oweakness in one part or side of body. oslurred speech. oleg swelling. ofever gets worse or lasts more than days. onasal congestion lasts for more than days. osymptoms continue or get worse. oredness or swelling is present in the painful area. oyou get nervous, dizzy, or sleepless. oany new symptoms appear.

OTC - WHEN USING SECTION.


When using this product. otake with food or milk if stomach upset occurs. otake with food or milk if stomach upset occurs.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


PRINCIPAL DISPLAY PANEL 200 mg/30 mg Caplet Blister Pack Carton. NDC 0363-0423-41WalgreensCompare to the activeingredients in Advil (R) Cold Sinus ++ WALGREENS PHARMACIST RECOMMENDED+oNON-DROWSYCold Sinus DCOLD SINUSIBUPROFEN PSEUDOEPHEDRINE HCl TABLETS, USPIBUPROFEN, USP 200 mg PAIN RELIEVER FEVER REDUCER (NSAID) PSEUDOEPHEDRINE HCl, USP 30 mg NASAL DECONGESTANTRelieves sinus pressure, nasal congestion fever40COATEDCAPLETSoval-shaped tablets nonsteroidal anti-inflammatory drugSEE NEW WARNINGS INFORMATION. Relieves sinus pressure, nasal congestion fever. PRINCIPAL DISPLAY PANEL 200 mg/30 mg Caplet Blister Pack Carton.

SPL UNCLASSIFIED SECTION.


Drug Facts.

STORAGE AND HANDLING SECTION.


Other information. ostore at 20 25 (68 77 F). Avoid excessive heat above 40 (104 F).oread all warnings and directions before use. Keep carton.. ostore at 20 25 (68 77 F). Avoid excessive heat above 40 (104 F).. oread all warnings and directions before use. Keep carton.

WARNINGS SECTION.


Warnings. Allergy alert. Ibuprofen may cause severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:ohivesofacial swellingoasthma (wheezing)oshockoskin reddeningorashoblistersIf an allergic reaction occurs, stop use and seek medical help right away.. ohives. ofacial swelling. oasthma (wheezing). oshock. oskin reddening. orash. oblisters. Stomach bleeding warning. This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:oare age 60 or olderohave had stomach ulcers or bleeding problemsotake blood thinning (anticoagulant) or steroid drugotake other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]ohave or more alcoholic drinks every day while using this productotake more or for longer time than directed. oare age 60 or older. ohave had stomach ulcers or bleeding problems. otake blood thinning (anticoagulant) or steroid drug. otake other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]. ohave or more alcoholic drinks every day while using this product. otake more or for longer time than directed. Heart attack and stroke warning. NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.. Do not use. oin children under 12 years of ageoif you have ever had an allergic reaction to any other pain reliever/fever reduceroright before or after heart surgeryoif 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.. oin children under 12 years of age. oif you have ever had an allergic reaction to any other pain reliever/fever reducer. oright before or after heart surgery. oif 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. ostomach bleeding warning applies to youoyou have problems or serious side effects from taking pain relievers or fever reducersoyou have history of stomach problems, such as heartburnoyou have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland, or had strokeoyou are taking diuretic. ostomach bleeding warning applies to you. oyou have problems or serious side effects from taking pain relievers or fever reducers. oyou have history of stomach problems, such as heartburn. oyou have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland, or had stroke. oyou are taking diuretic. Ask doctor or pharmacist before use if you are. ounder doctors care for any serious conditionotaking any other product that contains pseudoephedrine or any other nasal decongestantotaking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirinotaking any other drug. ounder doctors care for any serious condition. otaking any other product that contains pseudoephedrine or any other nasal decongestant. otaking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin. otaking any other drug. When using this product. otake with food or milk if stomach upset occurs. otake with food or milk if stomach upset occurs. Stop use and ask doctor if. oyou experience any of the following signs of stomach bleeding:ofeel faintovomit bloodohave bloody or black stoolsohave stomach pain that does not get betteroyou have symptoms of heart problems or stroke:ochest painotrouble breathingoweakness in one part or side of bodyoslurred speecholeg swellingofever gets worse or lasts more than daysonasal congestion lasts for more than daysosymptoms continue or get worseoredness or swelling is present in the painful areaoyou get nervous, dizzy, or sleeplessoany new symptoms appear. oyou experience any of the following signs of stomach bleeding:ofeel faintovomit bloodohave bloody or black stoolsohave stomach pain that does not get better. ofeel faint. ovomit blood. ohave bloody or black stools. ohave stomach pain that does not get better. oyou have symptoms of heart problems or stroke:ochest painotrouble breathingoweakness in one part or side of bodyoslurred speecholeg swelling. ochest pain. otrouble breathing. oweakness in one part or side of body. oslurred speech. oleg swelling. ofever gets worse or lasts more than days. onasal congestion lasts for more than days. osymptoms continue or get worse. oredness or swelling is present in the painful area. oyou get nervous, dizzy, or sleepless. oany new symptoms appear. If pregnant or breast-feeding, ask health professional before use. It is especially important not to use ibuprofen during the last months of pregnancy unless definitely directed to do so by doctor because it may cause problems in the unborn child or complications during delivery.. Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away (1-800-222-1222).