Advil Sinus Congestion and Pain Relief IBUPROFEN PHENYLEPHRINE HYDROCHLORIDE NAVAJO MANUFACTURING COMPANY INC. FDA Approved Uses • temporarily relieves these symptoms associated with the common cold or flu: • headache • fever • sinus pressure • nasal congestion • minor body aches and pains • reduces swelling of the nasal passages • temporarily restores freer breathing through the nose
FunFoxMeds box
Substance Ibuprofen
Route
ORAL
Applications
NDA022565

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each tablet) Ibuprofen 200 mg (NSAID)* Phenylephrine HCl 10 mg *nonsteroidal anti-inflammatory drug Purpose Pain reliever/fever reducer Nasal decongestant
Inactive Ingredients
Inactive ingredients acesulfame potassium artificial flavor carnauba wax colloidal silicon dioxide corn starch croscarmellose sodium glycerin hypromellose lactic acid lecithin maltodextrin medium-chain triglycerides microcrystalline cellulose pharmaceutical ink polydextrose polyvinyl alcohol pregelatinized starch propyl gallate sodium lauryl sulfate stearic acid sucralose synthetic iron oxide talc titanium dioxide triacetin xanthan gum
Strengths
200 mg 10 mg
Treats Conditions
Uses Temporarily Relieves These Symptoms Associated With The Common Cold Or Flu Headache Fever Sinus Pressure Nasal Congestion Minor Body Aches And Pains Reduces Swelling Of The Nasal Passages Temporarily Restores Freer Breathing Through The Nose
Pill Appearance
Shape: oval Color: brown Imprint: 1200;P10

Identifiers & Packaging

Container Type UNKNOWN
UNII
WK2XYI10QM 04JA59TNSJ
Packaging

Package Labeling: Advil Sinus

Package Descriptions
  • Package Labeling: Advil Sinus

Overview

Uses • temporarily relieves these symptoms associated with the common cold or flu: • headache • fever • sinus pressure • nasal congestion • minor body aches and pains • reduces swelling of the nasal passages • temporarily restores freer breathing through the nose

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 • reduces swelling of the nasal passages • temporarily restores freer breathing through the nose

Dosage & Administration

Directions • do not take more than directed • adults and children 12 years of age and over: • take 1 tablet every 4 hours while symptoms persist • do not use more than 6 tablets in any 24-hour period unless directed by a doctor • children under 12 years of age: do not use because this product contains too much medication for children under this age

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 • rash • skin reddening • 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 • in children under 12 years of age because this product contains too much medication for children under this 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 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 product that contains phenylephrine or any other nasal decongestant • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin • taking any other drug 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 • pain gets worse or lasts more than 7 days • 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 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.
Purpose

Purpose Pain reliever/fever reducer Nasal decongestant

Do Not Use

Do not use • in children under 12 years of age because this product contains too much medication for children under this 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 • 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 • pain gets worse or lasts more than 7 days • 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 right away.

Questions

Questions or comments? Call weekdays from 9 AM to 5 PM EST toll free at 1-800-88-ADVIL


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