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| Product NDC Code | 58809-198 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Vanatab dm |
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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 | TABLET | ||||||
| RxCUI drug identifier | 1874730 | ||||||
| Application Number | M012 | ||||||
| Labeler Name | GM Pharmaceuticals, Inc. | ||||||
| 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 Each caplet contains: Dextromethorphan HBr 9 mg Guaifenesin 198 mg Phenylephrine HCl 5 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 6 doses in any 24-hour period dose as follows or as directed by a doctor adults and children 12 years of age and over: 2 caplets every 4 hours children 6 to under 12 years of age: 1 caplet every 4 hours children under 6 years of age: consult a doctor
| adults and children 12 years of age and over: | |
| children 6 to under 12 years of age: | 1 caplet every 4 hours |
| children under 6 years of age: | consult a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients croscarmellose sodium, magnesium stearate, menthol, microcrystalline cellulose, polyethylene glycol, polysorbate, polyvinyl alcohol, pregelatinized starch, silicon dioxide, talc
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 rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep nasal congestion due to a cold
Purpose
Information about the drug product’s indications for use.Purpose Cough Suppressant Expectorant Nasal Decongestant
Spl product data elements
Usually a list of ingredients in a drug product.VanaTab DM Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl POLYSORBATE 20 GUAIFENESIN GUAIFENESIN MAGNESIUM STEARATE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED STARCH, PREGELATINIZED CORN SILICON DIOXIDE TALC CROSCARMELLOSE SODIUM MENTHOL 1-PROPYLENE GLYCOL CARBONATE, (-)- MICROCRYSTALLINE CELLULOSE white/off white 19
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.Distributed by: GM Pharmaceuticals Arlington, TX 76015 princpal display label onsert-1
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes a cough that lasts or is chronic such as occurs with smoking asthma, or emphysema a cough that occurs with too much phlegm (mucus) difficulty in urination due to enlargement of the prostate gland
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Store at 68-77 o F (20-25 o C).
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 1-888-535-0305 9 a.m. - 5 p.m. CST.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if: nervousness, dizziness or sleeplessnss occurs sysmtoms do not improve within 7 days or are accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition. new symptoms occur
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this poduct do not use more than directed
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professhional before use.
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
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