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| Product NDC Code | 63102-110 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Actidom dmx |
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| Type | Brand | ||||||
| Pharm Class | Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | SOLUTION | ||||||
| Application Number | M012 | ||||||
| Labeler Name | ACTIPHARMA, LLC | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients (in each 5 mL tsp) Dextromethorphan HBr, 30 mg Guaifenesin, 200 mg Phenylephrine HCl, 10 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions • do not take more than 4 doses in any 24-hour period. AGE DOSE Adults and Children 12 years of age and over Take 1 teaspoonfuls (5 mL) every 6 hours Children under 12 years of age ask a doctor
| ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Citric acid, D&C Red #40, FD&C Blue #1, flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses • Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes • Temporarily relieves these symptoms occurring with a cold: • nasal congestion • cough due to minor throat and bronchial irritation.
Purpose
Information about the drug product’s indications for use.Purposes Cough suppressant Expectorant Nasal decongestant
Spl product data elements
Usually a list of ingredients in a drug product.ACTIDOM DMX DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CITRIC ACID MONOHYDRATE FD&C RED NO. 40 FD&C BLUE NO. 1 GLYCERIN METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE, UNSPECIFIED FORM SUCRALOSE Clear
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Packaging Actidom DMX
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Contains the same active ingredients as Dometuss ® -DMX* SUGAR FREE ALCOHOL FREE Grape Flavor Manufactured in USA with imported ingredients for ActiPharma. San Juan, PR 00917. www.actipharma.net. * Dometuss® DMX is a registered trademark of Domel Laboratories. This product is not manufactured, distributed or marketed by Domel Laboratories.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? call weekdays from 8AM to 4PM AST at 1.787.608.0882
Storage and handling
Information about safe storage and handling of the drug product.Other information • Tamper Evident Feature: Do not use if safety seal is torn, cut or opened. • Store at controlled room temperature 15° - 30ºC (59º - 86ºF). • Avoid excessive heat or humidity.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema. Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant. When using this product • do not exceed recommended dosage Stop use and ask a doctor if • you get nervous, dizzy or sleepless • symptoms do not get better within 7 days or are accompanied by fever • coughs lasts more than 7 days, comes back, or is accompanied by fever, rash, or a persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API