Drug Facts
Composition & Profile
Identifiers & Packaging
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg/30 mg (32 Tablets) AUROHEALTH NDC 58602-839-13 #Compare to the active ingredients of Advil ® Cold &Sinus Non-Drowsy COLD & SINUS RELIEF Ibuprofen and Pseudoephedrine Hydrochloride Tablets USP 200 mg/30 mg Ibuprofen USP 200 mg - Pain Reliever/Fever Reducer (NSAID) Pseudoephedrine Hydrochloride USP 30 mg - Nasal Decongestant Relieves Sinus Pressure Nasal Congestion and Fever 32 Coated Caplets † † Oval-Shaped tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg/30 mg (32 Tablets)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg/30 mg (32 Tablets) AUROHEALTH NDC 58602-839-13 #Compare to the active ingredients of Advil ® Cold &Sinus Non-Drowsy COLD & SINUS RELIEF Ibuprofen and Pseudoephedrine Hydrochloride Tablets USP 200 mg/30 mg Ibuprofen USP 200 mg - Pain Reliever/Fever Reducer (NSAID) Pseudoephedrine Hydrochloride USP 30 mg - Nasal Decongestant Relieves Sinus Pressure Nasal Congestion and Fever 32 Coated Caplets † † Oval-Shaped tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg/30 mg (32 Tablets)
Overview
Uses temporarily relieves these symptoms associated with the common cold or flu: headache fever sinus pressure nasal congestion minor body aches and pains
Indications & Usage
Uses temporarily relieves these symptoms associated with the common cold or flu: headache fever sinus pressure nasal congestion 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 Other information store at 20° to 25°C (68° to 77°F). Avoid excessive heat above 40ºC (104ºF). read all warnings and directions before use. Keep carton.
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 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.
Purpose
Purposes Pain reliever/fever reducer Nasal decongestant
Do Not Use
Do not use in children under 12 years of age if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery 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.
When Using
When using this product take with food or milk if stomach upset occurs
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 you have symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling fever gets worse or lasts more than 3 days nasal congestion lasts for more than 7 days symptoms continue or get worse redness or swelling is present in the painful area you get nervous, dizzy, or sleepless any new symptoms appear
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 (1-800-222-1222) right away.
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