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advil cold and sinus

Pharmaranks rates Advil Cold and Sinus 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Advil Cold and Sinus is a combination medicine containing Ibuprofen and Pseudoephedrine Hydrochloride.

Ibuprofen and Pseudoephedrine Hydrochloride · by Haleon US Holdings

72/100Limited · 1 source

Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →

Rated against independent regulatory sources·Last updated August 22, 2026·How we rate
Verified againstopenFDANIH DailyMedRxClass
$0.04 /mL
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Key facts

Active ingredient
Ibuprofen and Pseudoephedrine Hydrochloride
Form
Capsule, Tablet
Strength
Ibuprofen EQ 200MG Free Acid AND Potassium Salt; Pseudoephedrine Hydrochloride 30MG
Type
Over-the-counter (OTC)
Brand or generic
Brand-name
Manufacturer
Haleon US Holdings
Half-life
roughly 3 to 16 hours — the label does not give one number, because the elimination half-life depends on urine pH: about 3 to 6 hours when urine pH is 5 (acidic), and about 9 to 16 hours when urine pH is 8 (alkaline) (how long it stays in your system)
What the pharmacy pays
~$0.04 per ml — not your price
FDA application
NDA021374

What is Advil Cold and Sinus?

From the FDA label:Uses temporarily relieves these symptoms associated with the common cold or flu: headache fever sinus pressure nasal congestion minor body aches and pains

How to use

Advil Cold and Sinus is sold in more than one form (Capsule and Tablet), and each is dosed differently. The instructions below come from the FDA label for application NDA021374 — follow the label that came with the product you were actually prescribed.

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 capsule every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 capsule, 2 capsules may be used. do not use more than 6 capsules in any 24-hour period unless directed by a doctor children under 12 years of age: do not use

Warnings

Important safety information

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. 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, have trouble urinating due to an enlarged prostate gland, or had a stroke 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 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 If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in 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.

How long does Ibuprofen and Pseudoephedrine Hydrochloride stay in your body?

The elimination half-life of ibuprofen and pseudoephedrine hydrochloride is roughly 3 to 16 hours — the label does not give one number, because the elimination half-life depends on urine pH: about 3 to 6 hours when urine pH is 5 (acidic), and about 9 to 16 hours when urine pH is 8 (alkaline) — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is a genuinely variable half-life, not a fixed one. Pseudoephedrine is cleared mostly unchanged by the kidneys (55% to 96% of a dose appears unchanged in urine), and because it is a base, acidic urine traps and flushes it out faster while alkaline urine lets it be reabsorbed — hence the 3-6 h vs 9-16 h spread the label reports. No active metabolite to worry about: the label says less than 1% is metabolized in the liver, by N-demethylation, to an INACTIVE metabolite. It is not a prodrug. Kidney impairment: because clearance is renal, the label states pseudoephedrine "may accumulate in patients with renal impairment," and the product is to be generally avoided in these patients — expect a longer half-life, though the label does not quantify it. Liver impairment: no studies of pseudoephedrine were conducted in hepatic impairment, so the label gives no number; the product is likewise to be generally avoided. Older adults: this label gives no separate pseudoephedrine half-life for people 65+ (its geriatric pharmacokinetic data covers the antihistamine component only), but it warns that older adults are more likely to have adverse reactions to sympathomimetic amines. The half-life above is from the Clarinex-D 12 Hour label, which is where FDA-approved pseudoephedrine pharmacokinetics are published; standalone OTC pseudoephedrine products carry monograph "Drug Facts" labels that contain no pharmacokinetics section at all.

This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: CLARINEX-D 12 HOUR (desloratadine and pseudoephedrine sulfate) extended release tablets — Section 12.3 Pharmacokinetics, DailyMed.

Dosage forms

Capsule and Tablet

The forms currently marketed in the U.S., per the FDA National Drug Code Directory.

Ways to save

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Frequently asked questions

How is Advil Cold and Sinus rated?
pharmaranks gives Advil Cold and Sinus a composite score of 3.6 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
How much does Advil Cold and Sinus cost?
Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.04 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
Is there a coupon or discount for Advil Cold and Sinus?
pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Advil Cold and Sinus. To pay less, look for a store-brand version with the same active ingredient (Ibuprofen and Pseudoephedrine Hydrochloride), which is typically cheaper, and compare unit prices. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
Who makes Advil Cold and Sinus?
Advil Cold and Sinus is marketed by Haleon US Holdings. You can see Haleon US Holdings's full profile, rating, and other products on pharmaranks.
Is Advil Cold and Sinus a brand-name or generic drug?
Advil Cold and Sinus is a brand-name product with the active ingredient Ibuprofen and Pseudoephedrine Hydrochloride.
Is Advil Cold and Sinus available over the counter?
Yes. Advil Cold and Sinus is an over-the-counter (OTC) product — you can buy it without a prescription. Follow the label directions and ask a pharmacist if you're unsure whether it's right for you.
What forms does Advil Cold and Sinus come in?
Advil Cold and Sinus is currently marketed as capsule and tablet, per the FDA's National Drug Code Directory.
Is Advil Cold and Sinus FDA-registered?
Advil Cold and Sinus is on record with the U.S. FDA under application number NDA021374. You can verify this on its official FDA label.
Has Advil Cold and Sinus been recalled by the FDA?
Advil Cold and Sinus has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
Is Advil Cold and Sinus safe?
There's no single safe-or-not verdict. pharmaranks gives Advil Cold and Sinus a recall-safety score of 72/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.

Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.

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advil cold and sinus

72/100