Guiadrine DX
Name: Guiadrine DX
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Guiadrine DX - Clinical Pharmacology
Dextromethorphan is an antitussive agent which, unlike the isomeric levorphanol, has no analgesic or addictive properties. The drug acts centrally and elevates the threshold for coughing. It is about equal to codeine in depressing the cough reflex. In therapeutic dosage, dextromethorphan does not inhibit ciliary activity. Dextromethorphan is rapidly absorbed from the gastrointestinal tract, metabolized by the liver and excreted primarily in the urine.
Guaifenesin is an expectorant which increases respiratory tract fluid secretions and helps to loosen phlegm and bronchial secretions. By reducing the viscosity of secretions, guaifenesin increases the efficiency of the cough reflex and of ciliary action in removing accumulated secretions from the trachea and bronchi. Guaifenesin is readily absorbed from the gastrointestinal tract and is readily metabolized and excreted in the urine. Guaifenesin has a plasma half-life of one hour. The major urinary metabolite is β-(2-methoxyphenoxy) lactic acid.
Indications and Usage for Guiadrine DX
For the temporary relief of cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants and help loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes. This product helps to control the cough reflex that causes coughing.
Contraindications
Guiadrine™ DX is contraindicated in patients with a hypersensitivity to any of its ingredients. Guiadrine™ DX should not be used in patients receiving monoamine oxidase inhibitor therapy (MAOI) and for 14 days after stopping MAOI therapy.
PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
Breckenridge
Pharmaceutical, Inc.
NDC 51991-633-16
Guiadrine™ DX
Liquid
- Sugar Free
- Alcohol Free
Description: Each 5mL (one teaspoonful) for oral
administration contains:
| Dextromethorphan Hydrobromide, USP | 25 mg |
| Guaifenesin, USP | 225 mg |
Do not use if inner seal is broken or missing.
Rx Only
Net Contents:
16 fl. oz. (One Pint) 473 mL
| Guiadrine DX dextromethorphan hydrobromide and guaifenesin liquid | ||||||||||||||||||||||||
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| Labeler - Breckenridge Pharmaceutical, Inc. (150554335) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Trimed | 182050567 | MANUFACTURE | |
For the Consumer
Applies to dextromethorphan / guaifenesin: oral capsule, oral liquid, oral packet, oral solution, oral syrup, oral tablet, oral tablet extended release 12 hour
For Healthcare Professionals
Applies to dextromethorphan / guaifenesin: oral capsule, oral capsule extended release, oral elixir, oral granule, oral liquid, oral suspension extended release, oral tablet, oral tablet extended release
Nervous system
Nervous system side effects of dextromethorphan have included drowsiness and dizziness. Adverse effects, which have occurred at higher doses, include excitation, mental confusion, and opioid like respiratory depression. In some cases of abuse, patients have experienced euphoria, hyperactivity, mania, and auditory and visual hallucinations.[Ref]
Gastrointestinal
Gastrointestinal side effects have included nausea, vomiting and constipation.[Ref]
Dermatologic
Dermatologic side effects have included pruritus and rash.[Ref]
Hypersensitivity
Hypersensitivity side effects of dextromethorphan have included fixed-drug eruptions.[Ref]
Some side effects of Guiadrine DX may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.