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CALMYLIN PSE WITH CODEINE is a brand name for Guaifenesin, supplied as a syrup. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
Adverse reactions due to codeine phosphate may include drowsiness, nausea, vomiting and constipation. Infrequent adverse effects include palpitation, dry mouth, skin rash, pruritus and, rarely, hyperhidrosis and agitation have been reported.
Respiratory depression is seen in higher dosage, and there is a potential for tolerance, psychological dependence or physical dependence to occur. Diphenhydramine delivers a sedative effect. Alcohol and other CNS depressants may increase this effect.
REPORTING SUSPECTED SIDE EFFECTS To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on serious and unexpected effects of drugs. ca/medeffect.
NOTE:
Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice. 13 SYMPTOMS AND TREATMENT OF OVERDOSAGE In Case of Accidental Overdose: Call a Poison Control Centre or doctor immediately, even if you do not notice any signs or symptoms such as increased sweating, nausea, vomiting, stomach pain or loss of appetite.
Symptoms:
May result in euphoria, dysphoria, visual disturbance, hypotension and coma or death from respiratory depression.
Treatment:
Codeine: Typical Toxidrome: Narcotic/Opiate Specific Antidote: Naloxone HCl.
General Management:
Stabilize the patient (A, B, C's), undertake appropriate gastrointestinal tract decontamination procedures, initiate supportive care, administer antidote as needed (see manufacturer's product monograph), consult with a Regional Poison Control Centre regarding ongoing management, and arrange for appropriate follow-up care.
DOSAGE AND ADMINISTRATION Dosing Considerations CALMYLIN and CALMYLIN PSE with Codeine should not be used in children less than 12 years old. Before prescribing medication to suppress or modify cough, it is important to ascertain that the underlying cause of the cough is identified, that modification of the cough does not increase the risk of clinical or physiologic complications, and that appropriate therapy for the primary disease is provided.
14 Adults 12 years and over DOSAGE: CALMYLIN: 2 teaspoonful (10 mL) every three to four hours, maximum of 4 doses per day or as prescribed by a physician. CALMYLIN PSE WITH CODEINE: 2 teaspoonful (10 mL) every 4 hours, maximum of 4 doses per day or as prescribed by a physician.
Do not co-administer with other drugs containing same medicinal ingredients. 5 mg and ammonium chloride 125 mg.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Guaifenesin in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Non-medicinal ingredients in alphabetical order:
FD & C yellow # 6, alcohol, amaranth, glycerin, menthol, purified water, raspberry flavour, simethicone, sorbitol and sucrose. 28 kcal/5 mL. Gluten- and tartrazine- free. Bottles of 100 mL, 250 mL and 350 mL. 33 mg, pseudoephedrine hydrochloride 30 mg and guaifenesin 100 mg.
Non-medicinal ingredients in alphabetical order:
FD & C yellow # 6, alcohol, amaranth, citric acid, glycerin, maltitol, menthol, methylparaben, propyleneglycol, propylparaben, purified water, raspberry flavour, sodium chloride, sodium citrate, sodium cyclamate and sorbitol. 42 kcal/5 mL.
Gluten-, tartrazine-, and sucrose -free. Bottles of 100 mL, 250 mL and 350 mL. STORAGE AND STABILITY Store between 15-30°C. 15 REFERENCES 1. 2005 AHFS (American Hospital Formulary Service) Drug Information Handbook published by the American Society of Health System Pharmacists.
2. Martindale, 33rd edition. 3.
American Hospital Formulary Service Drug Evaluation:
First Generation Antihistamines – Diphenhydramine Hydrochloride. McEvoy GK, editor.
Bethesda, Maryland:
American Society of Health-System Pharmacists, American Hospital Formulary Service Drug Information, 2005:16-20. 4. Thompson MICROMEDIX. com/hcs. 5. Thompson MICROMEDIX.
Antihistamines (Systemic):
USP DI DRUGDEX Evaluations 2005:341-358. 6. Health and Welfare Canada. Regulatory Proposals Regarding Antihistamines, Nasal Decongestants and Anticholinergics In Nonprescription Cough and Cold Remedies. 784, 1990. MORE INFORMATION Additional copies of this documentis available to health professionals by contacting the sponsor, Teva Canada Limited, at: 1-800-268-4127 ext.
com This leaflet was prepared by Teva Canada Limited.
Last revised:
November 20, 2013.
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