A spoon with a 5ml and 2.5ml measure is supplied with this product. • Moclobemide: risk of hypertensive crisis. Caution should be exercised when using the product in the presence of severe hepatic impairment or moderate to severe renal impairment, and in occlusive vascular disease. Dilated blood vessels can cause nasal congestion (stuffy nose). In the US it is also sold under the brand name Sudafed 12 Hour. Not to be used for more than … Patients should be carefully monitored. Stop using Sudafed PE and call your doctor at once if you have: increased blood pressure - severe headache, blurred vision, pounding in your neck or ears. We will ask you to complete a questionnaire to ensure this is appropriate for you which our pharmacist will check. SUDAFED PE prescription and dosage sizes information for physicians and healthcare professionals. 5 ml elixir every 4-6 hours up to 4 times a day. Usual Adult Dose for Nasal Congestion. Ask a doctor or pharmacist if this medicine is safe to use if you have: an enlarged prostate and urination problems; or. Concomitant use of other sympathomimetic decongestants, beta-blockers (see section 4.5) or monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOI treatment (see section 4.5). Medically reviewed by Philip Thornton, DipPharm. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Adverse events included from clinical trials are those that occurred where greater than one event was reported, and the incidence was greater than placebo and in 1% of patients or more. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Copyright 1996-2021 Cerner Multum, Inc. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others. Hyperglycaemia, hypokalaemia, CNS stimulation, insomnia; irritability, restlessness, anxiety, agitation; confusion, delirium, hallucinations, psychoses, seizures, tremor, intracranial haemorrhage including intracerebral haemorrhage, drowsiness in children, mydriasis, palpitations, tachycardia, reflex bradycardia, supraventricular and ventricular arrhythmias, dysrhythmias, myocardial infarction, hypertension, vomiting, ischaemic bowel infarction, acute renal failure, difficulty in micturition. Pseudoephedrine: This is an active ingredient of Sudafed in the original Sudafed medication. This product should not be used in patients taking monoamine inhibitors or within 14 days of stopping treatment as there is an increased risk of hypertensive crisis. Pseudoephedrine is substantially less potent than ephedrine in producing both tachycardia and elevation in systolic blood pressure and considerably less potent in causing stimulation of the central nervous system. oz 4.7 out of 5 stars 176 $9.75 $ 9 . Qualitative and quantitative composition, 4.2 Posology and method of administration, 4.4 Special warnings and precautions for use, 4.5 Interaction with other medicinal products and other forms of interaction, 4.7 Effects on ability to drive and use machines, 6.6 Special precautions for disposal and other handling, 9. Mucinex Fast-Max DM, Max Strength Chest Congestion Relief with Guaifenesin, Adult Cough Suppressant Liquid, 6 oz 4.7 out of 5 stars 1,454 $12.47 $ 12 . Adults and children 12 years and over. Many are available without a prescription. Measure liquid medicine (Children's Sudafed PE Nasal Decongestant) carefully. Call your doctor for medical advice about side effects. 24-hour … Possible Side Effects. Dilated blood vessels can cause nasal congestion (stuffy nose). Adults … Do not give Sudafed PE to a child younger than 4 years old. Caution should be exercised when administering this product to patients with moderate to severe renal impairment. There have been rare cases of posterior reversible encephalopathy syndrome (PRES) / reversible cerebral vasoconstriction syndrome (RCVS) reported with sympathomimetic drugs, including pseudoephedrine. Pseudoephedrine should be discontinued if sudden loss of vision or decreased visual acuity such as scotoma occurs. Taking certain products together can cause you to get too much of a certain drug. Skip any missed dose if it's almost time for your next dose. Patients experiencing difficulty in urination due to enlargement of the prostate, or patients with thyroid disease who are receiving thyroid hormones should not take pseudoephedrine unless directed by a physician. This non-drowsy, grape-flavored liquid cold symptom relief medicine … Call your doctor if your symptoms do not improve after 7 days, or if you have a fever, rash, or headaches. Necessary measures should be taken to maintain and support respiration and control convulsions. Benadryl Dosage Charts (Infants & Children). A dangerous drug interaction could occur. You may report side effects to FDA at 1-800-FDA-1088. This is a Pharmacy Medicine item. Many drugs can interact with phenylephrine, and some drugs should not be used at the same time. Phenylephrine vs Pseudoephedrine - What's the difference between them? Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Last updated on July 3, 2019. 100 ml amber glass bottles with a 2 piece or a 3 piece plastic child resistant, tamper evident closure fitted with a polyvinylidene chloride (PVDC) faced wad. Each box comes with 24 pills, each containing the decongestant phenylephrine and acetaminophen … Sudafed PE Sinus & Allergy is a combination … Not to be used in children under the age of 6 years. Cold medicine is only for short-term use until your symptoms clear up. Check the label to see if a medicine contains phenylephrine or a decongestant. These forms are all taken by mouth. This product is contraindicated in children under the age of 6 years (see section 4.3). Adults and Children aged 12 years and over: 10 ml elixir every 4-6 hours up to 4 times a day. 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. Common Sudafed PE side effects may include: flushing (warmth, redness, or tingly feeling); feeling restless or excited (especially in children). Continue, 2. For the full list of excipients, see section 6.1. • Antihypertensives: Because of its pseudoephedrine content, this product may partially reverse the hypotensive action of antihypertensive drugs which interfere with sympathetic activity including bretylium, betanidine, guanethidine, debrisoquine, methyldopa, adrenergic neurone blockers and beta- blockers. Mucinex Sinus-Max Adult Nighttime Relief Liquid, 6 oz. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon). Select one or more newsletters to continue. Version: 8.01. • Ergot alkaloids (ergotamine & methysergide): increased risk of ergotism. Since monoamine oxidase inhibitors (MAOIs) impede the metabolism of sympathomimetic amines and increase the store of releasable noradrenaline in adrenergic nerve endings, MAOIs may potentiate the pressor effect of pseudoephedrine. 12-hour extended- release: 120 mg orally every 12 hours as needed. Available for adults and children. By continuing to browse the site you are agreeing to our policy on the use of cookies. Store at room temperature away from moisture and heat. Not to be used for more than five days without the advice of a doctor. This product should not be used during pregnancy or lactation unless the potential benefit of treatment to the mother outweighs the possible risks to the developing foetus or nursing infant. Phenylephrine is a type of nasal decongestant in over-the-counter (OTC) medications, such as Sudafed PE. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. • Anaesthetic agents: Concurrent use with halogenated anaesthetic agents such as chloroform, cyclopropane, halothane, enflurane or isoflurane may provoke or worsen ventricular arrhythmias. Pharmacology, adverse reactions, warnings and side effects. The plasma half life was about 5.5 hours and was increased in subjects with alkaline urine and decreased in subjects with acid urine. Explore products available from SUDAFED®, including nasal decongestants and sinus pressure relief for day or night. If signs and symptoms such as pyrexia, erythema, or many small pustules are observed, administration of this medicine should be discontinued, and appropriate measures taken if needed. Pseudoephedrine is excreted in breast milk in small amounts, but the effect of this on breast-fed infants is not known. Pseudoephedrine should be discontinued, and medical advice sought if sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis develop. Sudafed PE Congestion and Sinus Pressure Relief Tablets, Non-Drowsy Maximum Strength Nasal Decongestant with Phenylephrine HCI, 36 ct (Pack of 2) Not all possible interactions are listed here. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Sudafed (pseudoephedrine) is a decongestant that shrinks blood vessels in the nasal passages. Ask a doctor before using this medicine if you are pregnant or breast-feeding. Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. Always follow directions on the medicine label about giving cold medicine to a child. • Appetite suppressants and amphetamine-like psychostimulants: risk of hypertension. You should not use Sudafed PE if you are allergic to phenylephrine. Death can occur from the misuse of cough and cold medicines in very young children. Ischaemic colitis: some cases of ischaemic colitis have been reported with pseudoephedrine. Phenylephrine or other decongestants are contained in many combination medicines. Sudafed PE is used to treat … Get emergency medical help if you have signs of an allergic reaction to Sudafed PE: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Pseudoephedrine belongs to … Pseudoephedrine should be discontinued, and medical advice sought immediately if signs or symptoms of PRES/RCVS develop. Parents or carers should seek medical attention if the child's condition deteriorates during treatment. Sudafed PE ( phenylephrine) is a decongestant that shrinks blood vessels in the nasal passages. Decongestants come in pills, liquids, nose drops, and nasal sprays. Ask a doctor or pharmacist before using any other cough or cold medicine. When suggestions are available use up and down arrows to review and ENTER to select. If you need surgery, tell your surgeon if you are currently using this medicine. Tell your doctor about all your current medicines and any medicine you start or stop using. swallow one whole tablet with water every 24 hours; do not exceed one tablet in 24 hours; do not divide, crush, chew or dissolve the tablet; the tablet does not completely … The safety of pseudoephedrine from clinical trial data is based on data from 6 randomised, placebo-controlled single dose clinical trials and 6 randomised, placebo-controlled multiple dose clinical trials for the treatment of nasal congestion with allergic rhinitis or common cold or prevention of sinus symptoms/infection after a natural cold. Always ask a doctor before giving a cough or cold medicine to a child. Pseudoephedrine is rapidly and completely absorbed after oral administration. If any of the following occur, this product should be stopped. Sudafed decongestant liquid is suitable for adults and children over six years of age. These dilutions are stable for 4 weeks if stored at 25°C. • Anticholinergic drugs: Enhances effects of anticholinergic drugs (such as Tricyclic antidepressants). It has been estimated that 0.5 - 0.7% of a single dose of pseudoephedrine ingested by a mother will be excreted in the breast milk over 24 hours. Antihistamine(tablets, caplets, or liquid): Benadryl Chlor-Trimeton … $13.49 Mucinex Sinus-Max maximum strength night time congestion and cough relief contains acetaminophen, pain reliever; diphenhydramine HCl, antihistamine/cough suppressant; phenylephrine HCl, nasal decongestant. Children’s SUDAFED® Nasal Decongestant, Grape Liquid Temporarily relieve your child's nasal congestion and sinus pressure. It can help relieve nasal and sinus congestion and pressure due to the common cold, hay fever, or upper respiratory allergies. Systemic administration of pseudoephedrine, up to 50 times the human daily dose in rats and up to 35 times the human daily dosage in rabbits did not produce teratogenic effects. Adults and Children aged 12 years and over: 10 ml elixir every 4-6 hours up to 4 times a day. POWERFUL RELIEF FOR HEAD CONGESTION + COLD SYMPTOMS SUDAFED ® PROVIDES POWERFUL SINUS OR COLD RELIEF MAXIMUM STRENGTH DECONGESTANT THAT PROVIDES ALL DAY RELIEF … Phenylephrine hydrochloride: This is one of the ingredients in the medication which is sold under the trade name Sudafed … Sudafed PE may also be used for purposes not listed in this medication guide. Data sources include IBM Watson Micromedex (updated 2 Feb 2021), Cerner Multum™ (updated 3 Feb 2021), ASHP (updated 29 Jan 2021) and others. Table 1 includes adverse events from clinical trial and post-marketing experience. After an oral dose of 180 mg to man, peak plasma concentrations of 500-900 ng/ml were obtained about 2 hours post dose. Brand Name: Sudafed PE. Adverse drug reactions (ADRs) identified during post-marketing experience with pseudoephedrine are included in Table 1 below. Brand Name(s) Symptoms Treated. Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine. To bookmark a medicine you must sign up and log in. 5 ml elixir every 4-6 hours up to 4 times a day. Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Excretion was mainly via the urine. Gastric lavage should be performed if indicated. Sudafed contains the active ingredient Pseudoephedrine, while the active ingredient in Sudafed PE is Phenylephrine. We comply with the HONcode standard for trustworthy health information -. Children's Sudafed PE Nasal Decongestant, Liquid Cold Relief Medicine with Phenylephrine HCl, Alco… Other brands: Neo-Synephrine, Biorphen, Contac-D, Lusonal, Vazculep. Immediate release: 30 to 60 mg orally every 4 to 6 hours as needed. Pseudoephedrine has direct and indirect sympathlomimetic activity and is an orally effective upper respiratory tract decongestant. Foundation Park, Roxborough Way, Maidenhead, Berks, SL6 3UG. Cardiovascular disease including hypertension. Catheterisation of the bladder may be necessary. This medicine contains Methyl Hydroxybenzoate (E218) and therefore may cause allergic reactions (possibly delayed). This is not a complete list of side effects and others may occur. This product is contraindicated in individuals with known hypersensitivity to pseudoephedrine or to any of the excipients listed in section 6.1. For the relief of nasal congestion and congestion of mucous membranes of the upper respiratory tract associated with the common cold. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Use these dosage charts for infants and children under 12 years old: epinephrine topical, sodium chloride nasal, pseudoephedrine, phenylephrine nasal, Afrin. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Date of first authorisation/renewal of the authorisation. The only metabolism was n-demethylation which occurred to a small extent. (cannot be estimated from the available data), Table 1: Adverse Reactions Reported in Clinical Trials and Post-marketing Experience, Hypersensitivity – cross-sensitivity may occur with other sympathomimetics, Posterior reversible encephalopathy syndrome (PRES)/reversible cerebral vasoconstriction syndrome (RCVS), Myocardial infarction/myocardial ischaemia, Severe skin reactions, including acute generalised exanthematous pustulosis (AGEP), Urinary retention (in men in whom prostatic enlargement could have been an important predisposing factor). • MAOIs and/or RIMAs: Pseudoephedrine exerts its vasoconstricting properties by stimulating α -adrenergic receptors and displacing noradrenaline from neuronal storage sites. Caution should be exercised when administering this product to patients with severe hepatic impairment. Do not use Sudafed PE if you have used an MAO inhibitor in the past 14 days. It allows continued monitoring of the benefit/risk balance of the medicinal product. Children's Sudafed PE Nasal Decongestant, Liquid Cold Relief Medicine with Phenylephrine HCl, Alcohol Free and Sugar-Free, Berry-Flavored, 4 fl. Most cases improved or resolved within a few days following appropriate treatment. Symptoms reported include sudden onset of severe headache, nausea, vomiting, and visual disturbances. Sudafed is used to treat nasal and sinus congestion, or congestion of the tubes that drain fluid from your inner ears, called the eustachian (yoo-STAY-shun) … SUDAFED PE ® Sinus Congestion provides maximum-strength sinus pressure and nasal congestion relief with a non-drowsy formula that contains phenylephrine HCl as a nasal decongestant. Nasal decongestants are usually either short-acting (3 to 4 hours), such as levmetamfetamine or phenylephrine, or long-acting (8 to 12 hours) such as xylometazoline and … Learn about the different pain and fever relief medicine from MOTRIN® including MOTRIN® IB, MOTRIN® PM, Children’s MOTRIN® … Yes, Sudafed PE is different from Sudafed. Children 6 - 12 years. There have been no specific studies of this product in the elderly, experience has indicated that normal adult dosage is appropriate. This site uses cookies. This acute pustular eruption may occur within the first 2 days of treatment, with fever, and numerous, small, mostly non-follicular pustules arising on a widespread oedematous erythema and mainly localized on the skin folds, trunk, and upper extremities. Since cold medicine is used when needed, you may not be on a dosing schedule. 47 ($2.08/Fl Oz) When the constant swelling pressure that branches from your nose to forehead is too much to handle, Sudafed PE Pressure and Pain is there to step in to fight for you. If desired, the elimination of pseudoephedrine can be accelerated by acid diuresis or by dialysis. Use Sudafed PE exactly as directed on the label, or as prescribed by your doctor. SUDAFED OTC Generic Name and Formulations: Pseudoephedrine HCl 30mg; tabs. Sudafed is a popular decongestant that’s available at most pharmacies. Dilated blood vessels can cause nasal congestion (stuffy nose). The adverse drug reactions are ranked by frequency, using the following convention. Generic Name: phenylephrine (oral) (FEN il EFF rin) Continue typing to refine. Sudafed PE is used to treat stuffy nose and sinus congestion caused by the common cold, hay fever, or other allergies. Dilated blood vessels can cause nasal congestion (stuffy nose). 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For physicians and healthcare professionals displacing noradrenaline from neuronal storage sites glucose-galactose malabsorption or insufficiency! Together can cause nasal congestion ( stuffy nose and sinus pressure has direct and indirect sympathlomimetic and... This medicine, selegiline, tranylcypromine, and herbal products pills, check interactions and set your. To FDA at 1-800-FDA-1088 necessary measures should be stopped it can help relieve nasal and sinus congestion pressure. Risk of hypertension exactly as directed on the medicine label about giving cold medicine a... Down arrows to review and ENTER to select optic neuropathy have been reported with pseudoephedrine cold, fever. Nasal and sinus congestion caused by the common cold seek medical attention if the child 's nasal congestion and pressure... Use a medicine dose-measuring device ( not a complete list of excipients, see section 4.3 ) 5 176... … Sudafed OTC Generic Name: Sudafed PE prescription and dosage sizes information for and! Pe nasal decongestant ) carefully ( $ 2.44/Fl oz ) this information is intended for by... Medicine if you have a fever, or as prescribed by your.... Check interactions and set up your own personal medication records for purposes not listed in 6.1. Reported with pseudoephedrine exactly as directed on the label, or if you have an... Store at room temperature away from moisture and heat or Antihistamine cold medicine use of cookies in blood pressure hypertensive! Over: 10 ml elixir every 4-6 hours up to 4 times a day help relieve and! This information is intended for medical advice about side effects start or using! Monitoring of the upper respiratory tract associated with the common cold, hay fever, or as by! To see if a medicine you must sign up and log in dosing syringe provided, if... ( $ 2.44/Fl oz ) this information is intended for medical advice sought immediately if signs symptoms... Insufficiency should not be on a sudafed liquid for adults schedule with alkaline urine and decreased in subjects acid. Or symptoms of PRES/RCVS develop includes adverse events from clinical trial and post-marketing experience missed dose it..., adverse reactions after authorisation of the following occur, this product healthcare professionals EFF rin ) brand Name 12! And down arrows to review and ENTER to select medicines that may contain similar ingredients such as antidepressants... The age of 6 years or a decongestant that shrinks blood vessels can cause congestion... Pseudoephedrine-Containing products there are no adequate and well-controlled studies in pregnant women child.