The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Active Ingredients (In Each Caplet)
Ibuprofen, USP 200 mg (NSAID)*Pseudoephedrine HCl, USP 30 mg*nonsteroidal anti-inflammatory drug
Pain reliever/Fever reducerNasal decongestant
- Temporarily relieves these symptoms associated with the common cold or flu:feversinus pressurenasal congestionheadacheminor body aches and pains
- Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:hivesfacial swellingasthma (wheezing)shockskin reddeningrashblistersIf 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 olderhave had stomach ulcers or bleeding problemstake a blood thinning (anticoagulant) or steroid drugtake other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]have 3 or more alcoholic drinks every day while using this producttake 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 reducerif 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 ageright before or after heart surgery
Ask A Doctor Before Use If
- Stomach bleeding warning applies to youyou have problems or serious side effects from taking pain relievers or fever reducersyou have a history of stomach problems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes or have trouble urinating due to an enlarged prostate glandyou are taking a diuretic
Ask A Doctor Or Pharmacist Before Use If You Are
- Under a doctor’s care for any serious conditiontaking any other drugtaking any other product that contains pseudoephedrine or any other nasal decongestanttaking 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 occursthe 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 fainthave bloody or black stoolsvomit bloodhave stomach pain that does not get bettersymptoms continue or get worseany new symptoms appearyou get nervous, dizzy, or sleeplessfever gets worse or lasts more than 3 daysnasal congestion lasts for more than 7 daysredness 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).
- Do not take more than directedthe smallest effective dose should be usedadults 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 doctorchildren under 12 years of age: do not use
- 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.TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
Acacia, calcium carbonate, carnauba wax, confectioner’s sugar, corn starch, croscarmellose sodium, crospovidone, FD&C Blue no. 2 Aluminum Lake, FD&C Red no. 40 Aluminum Lake, FD&C Yellow no. 6 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
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