Codeine–guaifenesin

Selected Drug Facts describes temporary cough relief from minor throat/bronchial irritation with colds or inhaled irritants, and loosening/thinning mucus to make cough more productive. Persistent cough, chronic pulmonary disease, dyspnea, or excessive sputum needs clinician assessment rather than masking the cause. This is not a bronchitis antibiotic or a codeine pain regimen.

Westminster’s exact product is listed OTC MONOGRAPH DRUG M012 and Schedule V, not a product-specific approved NDA. Federal/state dispensing constraints still apply. FDA 2018 restricted prescription opioid cough labeling to adults 18+; its communication explicitly distinguishes OTC products still under consideration. The selected OTC label retains older pediatric directions. This clinical profile therefore covers adults only and does not misrepresent that Rx action as a formal amendment of this OTC label.

For adults 18 and older in this profile: 10 mL orally every 4 hours as directed; no more than 6 doses in 24 hours. Each 10 mL gives codeine phosphate 20 mg and guaifenesin 200 mg; maximum 60 mL/day gives 120 mg and 1,200 mg respectively. This is the selected label’s adult-volume limit, not the maximum for guaifenesin-only products or other codeine formulations. No scheduled long-term course is supplied.

Seek review if symptoms persist 7 days, recur, or occur with fever/rash/persistent headache. The OTC label’s age 12+ and 6–under 12 directions are not offered here as recommended pediatric dosing. FDA’s Rx age 18+ restriction and OTC legacy framework differ; pediatric treatment requires a separate current clinical/regulatory assessment and nonopioid alternatives discussion. No dose conversion from adult codeine analgesics or other cough mixtures is assumed.

Selected Drug Facts has no formal numbered contraindications section. It supplies clinician-assessment warnings for pulmonary disease, breathlessness, persistent cough, and excess mucus; absence of a formal section does not establish safety in severe breathing impairment. This adult-scoped profile supplies no pediatric regimen, and no analgesic-product formal contraindication list is falsely attributed to this OTC bottle.

The selected OTC label has no boxed warning; its display panel says may be habit-forming. FDA requires prominent opioid-risk boxed warnings on prescription cough labels. The source-specific difference is explicit: no-box OTC status is not proof that respiratory, addiction, overdose, or sedative-interaction risks are absent.

Drug Facts notes constipation may occur or worsen. FDA’s opioid class communication describes drowsiness/dizziness, nausea/vomiting, constipation, and slowed/difficult breathing, without assigning this exact product event rates. Marked sedation, breathing difficulty, or inability to awaken needs emergency care; suspected excess ingestion requires immediate medical/poison-center contact. No home antidote regimen, quantitative toxicity cutoff, or automatic safe maximum for a susceptible patient is supplied.

Avoid alcohol and combination with benzodiazepines, other opioids, sleep medicines, or other CNS depressants unless the treating clinician has assessed the risk and alternatives. FDA’s opioid-cough safety advice emphasizes profound sedation and respiratory harm. The selected OTC label provides no interaction-based dose reduction that reliably removes that risk.

Reconcile other codeine/guaifenesin and cough/cold ingredients before taking this solution; do not use another product’s guaifenesin-only maximum to increase this combination. Drug Facts does not provide a comprehensive metabolic-interaction study set or safe spacing rule. No CYP2D6/CYP3A4 inhibitor dosing algorithm or analgesic-to-cough conversion is invented.

OTC Drug Facts says to ask a health professional during pregnancy/breastfeeding and supplies no pregnancy regimen. FDA opioid-cough safety advice recommends against breastfeeding during treatment because drug in milk can harm the infant. This is precautionary clinical guidance beyond the older terse OTC wording, not an invented product-specific infant exposure number.

This profile intentionally excludes recommended under 18 dosing because of the current opioid-cough benefit-risk concerns. The OTC label retains pediatric directions, while FDA’s 18+ labeling action is for prescription products. No separate geriatric regimen or frailty trial is provided by this product label; assess pulmonary disease, sedation risk, and other medicines rather than assume the maximum suits every older adult.

Selected Drug Facts provides no product-specific organ-impairment PK study or validated CrCl/hepatic-stage adjustment. Do not interpret that gap as unrestricted use in severe disease or transplant a codeine analgesic regimen into this mixture. Clinician/pharmacist selection and monitoring must reflect the exact product and patient.

Codeine phosphate is labeled an antitussive; guaifenesin is an expectorant intended to loosen mucus/thin secretions and make cough more productive. This product label does not establish comparative benefit against nonopioid care or a disease-modifying pulmonary mechanism.

FDA describes hepatic CYP2D6 conversion of codeine to the more potent active metabolite morphine, with individual variation contributing to respiratory risk. The selected solution label supplies no measured formulation-specific bioavailability, plasma half-life, active-metabolite concentrations, or clearance/organ-impairment study. These values are not copied from codeine pain tablets or other opioid mixtures. A four-hour dosing interval is not proof of a four-hour half-life or absence of opioid accumulation/individual susceptibility.

Review duration/recurrence, sputum burden, fever/rash/headache, pulmonary disease and dyspnea, dosing accuracy, constipation, and medication duplication. Symptoms beyond 7 days need review. No universal laboratory interval or validated chronic opioid-cough monitoring plan is supplied by this Drug Facts label.

Use a calibrated mL device and the exact 10/100 mg-per 5 mL strength; never exceed the directed daily volume. Discuss other sedatives, alcohol, pregnancy/breastfeeding, and persistent breathing/cough symptoms. Secure the bottle from children and never share it. Seek immediate care for serious breathing / sedation changes or overdose; do not infer that pharmacist/OTC access means dependence-free treatment.

Westminster Codeine-Guaifenesin Oral Solution 10–100 mg/5 mL is a 473 mL bottle, NDC 69367-272-16; label describes sugar-, alcohol-, and dye-free formulation. SPL records Schedule V and OTC monograph M012. Federal Schedule V includes certain low-codeine cough mixtures; exact state access requirements and product-specific compliance must be checked separately, not guessed.

Covered oral solution contains codeine phosphate 10 mg and guaifenesin 100 mg per 5 mL. Other manufacturers, concentrations, extended-release products, codeine/chlorpheniramine or promethazine mixtures, hydrocodone combinations, and guaifenesin alone require their own labels; no injection/inhaled route is supplied.

Store at 15–30°C. Do not use if foil seal under the cap is broken/missing. Keep securely out of children’s reach, measure accurately, and follow package expiry; no unverified opened-bottle discard date or flavor/color identification is supplied.