guaifenesin and pseudoephedrine hydrochloride
Pharmaranks rates Guaifenesin and Pseudoephedrine Hydrochloride 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Guaifenesin and Pseudoephedrine Hydrochloride is a combination medicine containing Guaifenesin and Pseudoephedrine Hydrochloride.
Generic · by Granules
Generic of Mucinex D
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
- Guaifenesin and Pseudoephedrine Hydrochloride
- Form
- Tablet, extended release
- Strength
- Guaifenesin 1.2GM; Pseudoephedrine Hydrochloride 120MG · Guaifenesin 600MG; Pseudoephedrine Hydrochloride 60MG
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Granules
- 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
- ~$0.07 per ml — not your price
- FDA application
- ANDA216082
- Availability
- Discontinued (per FDA)
What is Guaifenesin and Pseudoephedrine Hydrochloride?
From the FDA label:Uses • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive • temporarily relieves nasal congestion due to: • common cold • hay fever • upper respiratory allergies • temporarily restores freer breathing through the nose • promotes nasal and/or sinus drainage • temporarily relieves sinus congestion and pressure
How to use
Directions • do not crush, chew, or break extended-release tablet • take with a full glass of water • this product can be administered without regard for timing of meals • adults and children 12 years and older: For 600 mg/60 mg: 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours For 1200 mg/120 mg: 1 extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours • children under 12 years of age: do not use
Warnings
Important safety information
Do not use 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 you have • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema • cough accompanied by too much phlegm (mucus) When using this product • do not use more than directed Stop use and ask a doctor if • you get nervous, dizzy, or sleepless • symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Centre right away (1-800 222-1222). Other information • Tamper evident: do not use if carton is open or if printed seal on blister is broken or missing. • store between 20-25°C (68-77°F)
How long does Guaifenesin and Pseudoephedrine Hydrochloride stay in your body?
The elimination half-life of guaifenesin 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
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
- How is Guaifenesin and Pseudoephedrine Hydrochloride rated?
- pharmaranks gives Guaifenesin and Pseudoephedrine Hydrochloride 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 Guaifenesin 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 $0.07 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 Guaifenesin and Pseudoephedrine Hydrochloride?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Guaifenesin and Pseudoephedrine Hydrochloride. To pay less, Guaifenesin 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 Guaifenesin and Pseudoephedrine Hydrochloride?
- Guaifenesin and Pseudoephedrine Hydrochloride is marketed by Granules. You can see Granules's full profile, rating, and other products on pharmaranks.
- Is Guaifenesin and Pseudoephedrine Hydrochloride a brand-name or generic drug?
- Guaifenesin and Pseudoephedrine Hydrochloride is a generic medication; its active ingredient is Guaifenesin and Pseudoephedrine Hydrochloride. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Guaifenesin and Pseudoephedrine Hydrochloride available over the counter?
- No. Guaifenesin and Pseudoephedrine Hydrochloride 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 Guaifenesin and Pseudoephedrine Hydrochloride come in?
- Guaifenesin and Pseudoephedrine Hydrochloride is currently marketed as tablet, extended release, per the FDA's National Drug Code Directory.
- Is Guaifenesin and Pseudoephedrine Hydrochloride FDA-registered?
- Guaifenesin and Pseudoephedrine Hydrochloride is on record with the U.S. FDA under application number ANDA216082. You can verify this on its official FDA label.
- Has Guaifenesin and Pseudoephedrine Hydrochloride been recalled by the FDA?
- Guaifenesin 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 Guaifenesin and Pseudoephedrine Hydrochloride safe?
- There's no single safe-or-not verdict. pharmaranks gives Guaifenesin and Pseudoephedrine Hydrochloride 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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guaifenesin and pseudoephedrine hydrochloride
72/100