Advil Cold and Sinus

Name: Advil Cold and Sinus

Dosing & Uses

Dosage Forms & Strengths

ibuprofen/pseudoephedrine

caplet

  • 200mg/30mg

liquid gel capsule

  • 200mg/30mg

Cold Symptoms

1 caplet/capsule PO q4-6hr PRN; may increase to 2 caplets/capsules q4-6hr if necessary while symptoms persist

Not to exceed 6 doses/24 hr

Administration

Take with food or milk if stomach upset occurs

Dosage Forms & Strengths

ibuprofen/pseudoephedrine

caplet

  • 200mg/30mg

liquid gel capsule

  • 200mg/30mg

Cold Symptoms

<12 years: Safety and efficacy not established

>12 years: 1 caplet/capsule PO q4-6hr PRN; may increase to 2 caplets/capsules q4-6hr if necessary while symptoms persist Not to exceed 6 doses/24 hr

Administration

Take with food or milk if stomach upset occurs

Pharmacology

Mechanism of Action

Ibuprofen: Inhibits synthesis of prostaglandins by inhibiting cyclooxygenase (COX-1, COX-2); may inhibit chemotaxis, alter lymphocyte activity, decrease proinflammatory cytoking activity, and inhibit neutrophil aggregation, which in turn may result in anti-inflammatory activity

Pseudoephedrine stimulates the alpha-adrenergic receptors causing bronchodilation and vasoconstriction

Pharmacokinetics

Ibuprofen

  • Absoroption: Rapid (85%)
  • Bioavailability: 80-100%
  • Onset: 30-60 min
  • Duration: 4-6 hr
  • Peak plasma concentration: 20 mcg/mL (tab)
  • Protein bound: 90-99%
  • Vd: 0.12 L/kg (adults); 0.2 L/kg (children)
  • Peak plasma time: 120 min (tab)
  • Metabolism: Rapid hepatic oxidation to inactivate metabolites; CYP2C9; CYP2C19 substrate
  • Half-life: 2-4hr
  • Excretion: Urine (50-60%); feces (50-40%)

Pseudoephedrine

  • Half-Life: 3 hr (children); 9-16 hr (adults)
  • Onset: 30 min (decongestant)
  • Duration: 3-8 hr  
  • Peak Plasma Time: 1.97 hr
  • Concentration: 422 ng/mL
  • Metabolism: Liver, by N-demethylation
  • Metabolites: Inactive
  • Clearance: 7.3-7.6 mL/min/kg
  • Excretion: Urine (43-96%)

What Is Advil Cold and Sinus?

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID). Ibuprofen works by reducing hormones that cause inflammation and pain in the body.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Ibuprofen and pseudoephedrine is a combination medicine used to treat stuffy nose, sinus congestion, cough, and pain or fever caused by the common cold or flu.

Ibuprofen and pseudoephedrine may also be used for purposes not listed in this medication guide.

Ibuprofen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Ibuprofen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning, especially in older adults.

Do not use ibuprofen and pseudoephedrine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Ibuprofen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while taking this medicine.

Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Ibuprofen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using ibuprofen and pseudoephedrine, especially in older adults.

You should not use this medicine if you are allergic to ibuprofen or pseudoephedrine, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

Do not use ibuprofen and pseudoephedrine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Do not give ibuprofen to a child younger than 12 years old.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

  • heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;
  • a history of heart attack, stroke, or blood clot;
  • a history of stomach ulcers or bleeding;
  • asthma;
  • liver or kidney disease;
  • a thyroid disorder;
  • diabetes; or
  • enlarged prostate, urination problems.

Taking ibuprofen during the last 3 months of pregnancy may harm the unborn baby. Do not use ibuprofen and pseudoephedrine without a doctor's advice if you are pregnant.

It is not known whether ibuprofen and pseudoephedrine passes into breast milk or if it could harm a nursing baby. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

Advil Cold and Sinus Side Effects

Get emergency medical help if you have signs of an allergic reaction: sneezing, runny or stuffy nose; wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat.

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.

Stop using this medicine and call your doctor at once if you have:

  • confusion, severe drowsiness, ringing in your ears, severe dizziness, feeling like you might pass out;
  • fast, pounding, or uneven heartbeat;
  • easy bruising or bleeding (nosebleeds, bleeding gums);
  • the first sign of any skin rash, no matter how mild;
  • signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • liver problems--upper stomach pain, vomiting, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • kidney problems--little or no urinating, painful or difficult urination, swelling or rapid weight gain, feeling tired or short of breath;
  • nerve problems--fever, headache, neck stiffness, chills, increased sensitivity to light, seizure (convulsions); or
  • severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • diarrhea, constipation;
  • headache, dizziness, drowsiness, weakness;
  • upset stomach, nausea, vomiting, loss of appetite;
  • feeling anxious or excited;
  • sleep problems (insomnia); or
  • flushing (warmth, redness, or tingly feeling).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Purposes

Pain reliever/fever reducer

Nasal decongestant

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

  • 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.

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 pseudoephedrine 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
  • 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.

Inactive ingredients

acetylated monoglycerides, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, methylparaben, microcrystalline cellulose, pharmaceutical glaze, pharmaceutical ink, povidone, pregelatinized starch, propylparaben, sodium benzoate, sodium lauryl sulfate, stearic acid, sucrose, synthetic iron oxides, titanium dioxide

Product packaging

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

See new warnings information

Advil COLD & SINUS

Non-Drowsy

Ibuprofen 200 mg >> Pain Reliever/Fever Reducer (NSAID)

Pseudoephedrine HCl 30 mg >> Nasal Decongestant

Relieves Sinus Pressure, Nasal Congestion and Fever

20 COATED CAPLETS*

*Oval-Shaped Tablets

Wyeth Consumer Healthcare, Madison, NJ 07940 USA ©2009 Wyeth

For most recent product information, visit www.advil.com

Appearance of the tan Advil Cold & Sinus caplet is a trademark of Wyeth Consumer Healthcare

Product inside sealed in plastic blister with foil backing. Do Not Use if plastic blister or foil barrier is broken.

READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

LIFT HERE For More Drug Facts

Advil Cold and Sinus 
ibuprofen, pseudoephedrine hcl tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0180
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ibuprofen (ibuprofen) ibuprofen 200 mg
pseudoephedrine hydrochloride (pseudoephedrine) pseudoephedrine hydrochloride 30 mg
Product Characteristics
Color BROWN (butterscotch) Score no score
Shape CAPSULE (oblong) Size 14mm
Flavor Imprint Code Advil;Cold;Sinus
Contains     
Packaging
# Item Code Package Description
1 NDC:0573-0180-10 2 BLISTER PACK (BLISTER PACK) in 1 CARTON
1 10 TABLET, COATED (TABLET) in 1 BLISTER PACK
2 NDC:0573-0180-21 4 BLISTER PACK (BLISTER PACK) in 1 CARTON
2 10 TABLET, COATED (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019771 09/19/1989
Labeler - Pfizer Consumer Healthcare (828831730)
Establishment
Name Address ID/FEI Operations
Wyeth Pharmaceuticals Company, Consumer Site 829390975 MANUFACTURE, ANALYSIS
Revised: 06/2010   Pfizer Consumer Healthcare
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