naproxen sodium and pseudoephedrine hydrochloride

What is Naproxen Sodium and Pseudoephedrine Hydrochloride?

From the FDA label:Uses temporarily relieves these cold, sinus, and flu symptoms: sinus pressure minor body aches and pains headache nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose) fever

How to use

Naproxen Sodium and Pseudoephedrine Hydrochloride is sold in more than one form (Tablet, Tablet, extended release and Multilayer, extended release), and each is dosed differently. The instructions below come from the FDA label for application ANDA076518 — follow the label that came with the product you were actually prescribed.

Warnings

How long does Naproxen Sodium and Pseudoephedrine Hydrochloride stay in your body?

The elimination half-life of naproxen sodium 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.

Frequently asked questions

How is Naproxen Sodium and Pseudoephedrine Hydrochloride rated?

pharmaranks gives Naproxen Sodium and Pseudoephedrine Hydrochloride a composite score of 3.2 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 Naproxen Sodium and Pseudoephedrine Hydrochloride 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 $0.06 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. Pharmacies pay less for a same-class option, Advil Pm — about $0.04 on the same basis.

Is there a coupon or discount for Naproxen Sodium and Pseudoephedrine Hydrochloride?

pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Naproxen Sodium and Pseudoephedrine Hydrochloride. To pay less, Naproxen Sodium and Pseudoephedrine Hydrochloride is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.

Who makes Naproxen Sodium and Pseudoephedrine Hydrochloride?

Naproxen Sodium and Pseudoephedrine Hydrochloride is marketed by Perrigo. You can see Perrigo's full profile, rating, and other products on pharmaranks.

Is Naproxen Sodium and Pseudoephedrine Hydrochloride a brand-name or generic drug?

Naproxen Sodium and Pseudoephedrine Hydrochloride is a generic medication; its active ingredient is Naproxen Sodium and Pseudoephedrine Hydrochloride. Generics contain the same active ingredient as the brand-name original and are usually lower cost.

Is Naproxen Sodium and Pseudoephedrine Hydrochloride available over the counter?

Yes. Naproxen Sodium and Pseudoephedrine Hydrochloride 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 Naproxen Sodium and Pseudoephedrine Hydrochloride come in?

Naproxen Sodium and Pseudoephedrine Hydrochloride is currently marketed as tablet, tablet, extended release and multilayer, extended release, per the FDA's National Drug Code Directory.

Is Naproxen Sodium and Pseudoephedrine Hydrochloride FDA-registered?

Naproxen Sodium and Pseudoephedrine Hydrochloride is on record with the U.S. FDA under application number ANDA076518. You can verify this on its official FDA label.

Has Naproxen Sodium and Pseudoephedrine Hydrochloride been recalled by the FDA?

Naproxen Sodium and Pseudoephedrine Hydrochloride 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 Naproxen Sodium and Pseudoephedrine Hydrochloride safe?

There's no single safe-or-not verdict. pharmaranks gives Naproxen Sodium and Pseudoephedrine Hydrochloride a recall-safety score of 64/100, 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.