sudafed 12 hour
Pharmaranks rates Sudafed 12 Hour 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Sudafed 12 Hour (Pseudoephedrine Hydrochloride) is an alpha-adrenergic agonist used to treat Asthma, Common Cold, Perennial Allergic Rhinitis, Sinusitis.
Pseudoephedrine Hydrochloride · by Glaxosmithkline
Available as a generic: Pseudoephedrine Hydrochloride
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 →
Key facts
- Active ingredient
- Pseudoephedrine Hydrochloride
- Drug class
- Alpha-Adrenergic Agonist
- Form
- Capsule, extended release, Tablet, extended release
- Strength
- Pseudoephedrine Hydrochloride 120MG **Federal Register Determination That Product was not Discontinued or Withdrawn for Safety or Effectiveness reasons**
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- asthma, common cold, perennial allergic rhinitis
- Manufacturer
- Glaxosmithkline
- 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
- ~$8.29 for 30 — not your price
- FDA application
- NDA017941
- Availability
- Discontinued (per FDA)
How long does Pseudoephedrine Hydrochloride stay in your body?
The elimination half-life of 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.
Drug class
How this class works, per Alpha-1 Receptor Agonists - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
Dosage forms
Capsule, extended release and Tablet, extended release
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Sudafed 12 Hour treat?
- Sudafed 12 Hour (Pseudoephedrine Hydrochloride) may be used to treat asthma, common cold, perennial allergic rhinitis, sinusitis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Sudafed 12 Hour work?
- Sudafed 12 Hour is a alpha-adrenergic agonist. Alpha-adrenergic agonists switch on alpha receptors on blood-vessel walls, much like the body's own adrenaline. This tightens the smooth muscle around the vessels, narrowing them to raise blood pressure or reduce swelling and congestion.
- How is Sudafed 12 Hour rated?
- pharmaranks gives Sudafed 12 Hour a composite score of 3.5 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 Sudafed 12 Hour 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 $8.29 for 30, 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 Sudafed 12 Hour?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Sudafed 12 Hour. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Sudafed 12 Hour?
- Sudafed 12 Hour is marketed by Glaxosmithkline. You can see Glaxosmithkline's full profile, rating, and other products on pharmaranks.
- Is Sudafed 12 Hour a brand-name or generic drug?
- Sudafed 12 Hour is a brand-name product with the active ingredient Pseudoephedrine Hydrochloride. Lower-cost generic equivalents containing Pseudoephedrine Hydrochloride are available — ask your pharmacist.
- Is Sudafed 12 Hour available over the counter?
- No. Sudafed 12 Hour is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Sudafed 12 Hour come in?
- Sudafed 12 Hour is currently marketed as capsule, extended release and tablet, extended release, per the FDA's National Drug Code Directory.
- What class of drug is Sudafed 12 Hour?
- Sudafed 12 Hour is classified as alpha-adrenergic agonist, per the FDA's Established Pharmacologic Class.
- Is Sudafed 12 Hour FDA-registered?
- Sudafed 12 Hour is on record with the U.S. FDA under application number NDA017941. You can verify this on its official FDA label.
- Has Sudafed 12 Hour been recalled by the FDA?
- Sudafed 12 Hour 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 Sudafed 12 Hour safe?
- There's no single safe-or-not verdict. pharmaranks gives Sudafed 12 Hour a recall-safety score of 70/100, 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.
Information is sourced from public FDA regulatory data. Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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sudafed 12 hour
70/100