wal profen cold and sinus Ibuprofen, Pseudoephedrine Hydrochloride IBUPROFEN IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE ACACIA CALCIUM CARBONATE CARNAUBA WAX STARCH, CORN CROSCARMELLOSE SODIUM CROSPOVIDONE (15 MPA.S AT 5%) FD&C BLUE NO. 2 FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GUAR GUM HYDROXYPROPYL CELLULOSE (TYPE H) KAOLIN POLYETHYLENE GLYCOLS POWDERED CELLULOSE POVIDONES SILICON DIOXIDE SODIUM BENZOATE SUCROSE TALC TITANIUM DIOXIDE WHITE WAX 083
Drug Facts
Composition & Profile
Identifiers & Packaging
Principal Display Panel Compare to Advil® Cold & Sinus active ingredients NON-DROWSY WAL-PROFEN® COLD & SINUS Ibuprofen 200 mg/Pseudoephedrine HCl 30 mg Tablets, USP Pain Reliever/Fever Reducer (NSAID)*/ Nasal Decongestant Relieves Sinus Pressure, Nasal Congestion and Fever See New Warnings Information CAPLETS (**Oval-shaped tablets) *nonsteroidal anti-inflammatory drug Wal-Profen® Cold & Sinus Carton Image 1 Wal-Profen® Cold & Sinus Carton Image 2 Wal-Profen Cold & Sinus Carton Image 1 Wal-Profen Cold & Sinus Carton Image 2
- Principal Display Panel Compare to Advil® Cold & Sinus active ingredients NON-DROWSY WAL-PROFEN® COLD & SINUS Ibuprofen 200 mg/Pseudoephedrine HCl 30 mg Tablets, USP Pain Reliever/Fever Reducer (NSAID)*/ Nasal Decongestant Relieves Sinus Pressure, Nasal Congestion and Fever See New Warnings Information CAPLETS (**Oval-shaped tablets) *nonsteroidal anti-inflammatory drug Wal-Profen® Cold & Sinus Carton Image 1 Wal-Profen® Cold & Sinus Carton Image 2 Wal-Profen Cold & Sinus Carton Image 1 Wal-Profen Cold & Sinus Carton Image 2
Overview
Uses temporarily relieves these symptoms associated with the common cold or flu: • fever • sinus pressure • nasal congestion • headache • minor body aches and pains
Indications & Usage
Uses temporarily relieves these symptoms associated with the common cold or flu: • fever • sinus pressure • nasal congestion • headache • minor body aches and pains
Dosage & Administration
Directions • do not take more than directed • the smallest effective dose should be used • adults and children 12 years of age and over: • take 1 caplet every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 caplet, 2 caplets may be used. • do not use more than 6 caplets in any 24-hour period unless directed by a doctor • children under 12 years of age: do not use
Warnings & Precautions
Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: • hives • facial swelling • asthma (wheezing) • shock • skin reddening • rash • blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: • are age 60 or older • have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] • have 3 or more alcoholic drinks every day while using this product • take more or for a longer time than directed Do not use • if you have ever had an allergic reaction to any other pain reliever/fever reducer • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after 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. • in children under 12 years of age • right before or after heart surgery Ask a doctor before use if • stomach bleeding warning applies to you • you have problems or serious side effects from taking pain relievers or fever reducers • you have a history of stomach problems, such as heartburn • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes or have trouble urinating due to an enlarged prostate gland • you are taking a diuretic Ask a doctor or pharmacist before use if you are • under a doctor’s care for any serious condition • taking any other drug • taking any other product that contains pseudoephedrine or any other nasal decongestant • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin When using this product • take with food or milk if stomach upset occurs • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed Stop use and ask a doctor if • you experience any of the following signs of stomach bleeding: • feel faint • vomit blood • have bloody or black stools • have stomach pain that does not get better • symptoms continue or get worse • any new symptoms appear • you get nervous, dizzy, or sleepless • fever gets worse or lasts more than 3 days • nasal congestion lasts for more than 7 days • redness or swelling is present in the painful area If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a 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 a Poison Control Center right away. (1-800-222-1222)
Purpose
Purpose Pain reliever/Fever reducer Nasal decongestant
Do Not Use
Do not use • if you have ever had an allergic reaction to any other pain reliever/fever reducer • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after 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. • in children under 12 years of age • right before or after heart surgery
When Using
When using this product • take with food or milk if stomach upset occurs • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
Stop Use & Ask a Doctor
Stop use and ask a doctor if • you experience any of the following signs of stomach bleeding: • feel faint • vomit blood • have bloody or black stools • have stomach pain that does not get better • symptoms continue or get worse • any new symptoms appear • you get nervous, dizzy, or sleepless • fever gets worse or lasts more than 3 days • nasal congestion lasts for more than 7 days • redness or swelling is present in the painful area
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 at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F). • read all warnings and directions before use. Keep carton.
Questions
Questions or comments? 1-800-719-9260
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