Flora Force Herbal Cough Mixture Package Insert
Scheduling status: C0
Proprietary name (and dosage form): Flora Force Herbal Cough Mixture liquid.
Composition: Each 5ml of Cough Mixture contains 26mg Pimpinella anisum EQUIV, 52mg Glycorrhiza glabra aqueous EQUIV, 52mg Inula helenium EQUIV, 52mg Marrubium vulgare EQUIV, 52mg Prunus serotina EQUIV, 52mg Pulmonaria officinalis EQUIV, 52mg Pelargonium sidoides Herb EQUIV, 15mg Thymus vulgaris EQUIV, 52mg Lobelia inflata EQUIV, 30% Alcohol v/v.
Pharmacological classification: Category D Western Herbal Medicine
Pharmacological action: 10.1 Respiratory system, Antitussives and Expectorants
Indications: Herbal medicine for coughs, bronchial infections, colds and flu’s. Helps loosen phlegm and thin bronchial secretions for easy expectoration. Helps ease symptoms of sore throat and chest resulting from excessive coughing.
Contra-indications: Contains: Glycorrhiza glabra: contra-indicated in hypertension. Lobelia: contra-indicated if on heart medication. Marrubium: contra-indicated in pregnancy. Prunus serotina contra-indicated and should not be used in early pregnancy.
Warnings: No cough mixture should be used continuously without consulting a practitioner.
Drug, herb Interaction: For persons on any of the following drugs please consult with your practitioner.
Prednisone: Glycorrhiza glabra may prolong prednisone activity and prednisone related side effects.
Digoxin: Glycorrhiza glabra may have effect of extra potassium loss when large amounts consumed.
NSAIDs, Aspirin and Ibuprofen: Glycorrhiza glabra flavonoids can have protective action on GIT membranes. Potassium depleting drugs (loop diuretics and thiazide diuretics) Glycorrhiza glabra may potentiate side effects of these drugs.
Pregnancy and Lactation: Please consult with a healthcare practitioner before using the Herbal Cough Mixture.
Dosage and directions for use:
Adult: Take one teaspoon three times daily.
Children under 8 years: ½ teaspoon three times daily. Dilute in a little water for small children.
Or use as prescribed by practitioner.
Side-effects and special precautions: None reported on product. Known allergy to any of the ingredients.
Known symptoms of over dosage and particulars of its treatment: Nausea and vomiting. Treatment: stop intake, symptoms will abate; supportive: drink water.
Identification: Dark brown alcoholic liquid with liquorice flavour.
Presentation: 100ml Amber glass bottle with white tamper evident screw cap. 500ml Amber glass bottle with white tamper evident screw cap.
Storage instructions: Store in a cool dark place below 25ºC. KEEP OUT
OF REACH OF CHILDREN.
Registration number (or reference number): To be allocated.
Applicant: Flora Force Health Products (Pty) Ltd, PO Box 426, Rondebosch, 7701, Cape Town
Date of publication: 04/08/2015