Pseudoephedrine

The bundle re-fetched 2026-09-10 carries a DIFFERENT product after the brand-family fix: 'Sudafed Decongestant Tablets' (eMC product 6199), a single-ingredient pseudoephedrine tablet. §4.1 verbatim: 'Sudafed Decongestant Tablets is a decongestant of the mucous membranes of the upper respiratory tract, especially the nasal mucosa and sinuses and is indicated for the symptomatic relief of conditions such as allergic rhinitis, vasomotor rhinitis, the common cold and influenza.' That is exactly this page's primary identity — oral nasal decongestant (sympathomimetic), brand Sudafed, ENT / General Medicine — so the dose above is this indication's own dose. §4.2 verbatim: 'Adults and Children over 12 years 1 tablet every 4 - 6 hours up to 4 times a day.' TABLET STRENGTH — READ THIS BEFORE QUOTING A MILLIGRAM FIGURE. §4.2 doses this product in TABLETS and the fetched text never states the tablet strength. The only milligram figures anywhere in the fetched SPC are in §4.6, which says 'approximately 0.4 to 0.7% of a single 60 mg dose of pseudoephedrine ingested by a nursing mother will be excreted in the breast milk over 24 hours' and 'Data from a study of lactating mothers taking 60 mg pseudoephedrine every 6 hours suggests that from 2.2 to 6.7% of the maximum daily dose (240 mg) may be available to the infant from a breastfeeding mother.' The 240 mg maximum daily dose is therefore stated by the SPC itself and is quoted in maxDose above; 60 mg per tablet is CONSISTENT with it (240 mg / 4 doses) but is not written in the fetched text as a per-tablet strength, so the dose field is expressed in tablets rather than milligrams. Do not convert. SPECIAL POPULATIONS (§4.2 verbatim): 'Use in the Elderly There have been no specific studies of Sudafed Decongestant Tablets in the elderly. Experience has indicated that normal adult dosage is appropriate.' 'Hepatic Dysfunction Caution should be exercised when administering Sudafed Decongestant Tablets to patients with severe hepatic impairment.' 'Renal Dysfunction Caution should be exercised when administering Sudafed Decongestant Tablets to patients with moderate renal impairment.' Note §4.3 separately CONTRAINDICATES severe acute or chronic kidney disease/renal failure. Nothing on this page may be used to dose a child of 12 or under; use a children's formulary. US LABEL NOT USED. The openFDA arm is 'Pseudoephedrine hydrochloride' (The Kroger Company, label date 2021-04-13); its complete directions read 'adults and children 12 years and over take 1 tablet every 12 hours do not take more than 2 tablets in 24 hours children under 12 years do not use this product in children under 12 years of age'. That is a US OTC 12-hourly EXTENDED-RELEASE presentation, not the UK immediate-release tablet this page carries, and no figure has been taken from it. STOP RULES FROM §4.4 (these are discontinuation triggers, not routine monitoring): stop if hallucinations, restlessness or sleep disturbances occur; stop for severe skin reactions including acute generalised exanthematous pustulosis (AGEP), which 'may occur within the first 2 days of treatment'; stop and seek advice for sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis; stop for sudden loss of vision or decreased visual acuity such as scotoma (ischaemic optic neuropathy); stop and seek immediate medical assistance for sudden severe or thunderclap headache, nausea, vomiting, confusion, seizures and/or visual disturbances (PRES / RCVS), the risk of which 'is increased in patients with severe or uncontrolled hypertension, or with severe acute or chronic kidney disease/renal failure'. §4.4 also states patients with difficulty in urination and/or enlargement of the prostate, or patients with thyroid disease receiving thyroid hormones, should not take pseudoephedrine unless directed by a physician, and that this product contains lactose.