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| Product NDC Code | 58809-187 | ||||
|---|---|---|---|---|---|
| Drug Name | Vanacof xp cough / chest congestion |
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| Type | Brand | ||||
| Pharm Class | 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] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | SOLUTION | ||||
| RxCUI drug identifier | 2671189 | ||||
| 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 (in each 15 mL (1TBSP)) Dextromethorphan HBr 18 mg Guaifenesin 396 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 ■ mL= milliliter adults and children 12 years of age and over: 15 mL (1 TBSP) every 4 hours, not to exceed 90 mL (6 TBSP) per 24 hours children 6 to under 12 years of age: 7.5 mL (1/2 TBSP) every 4 hours, not to exceed 45 mL (3 TBSP) per 24 hours children under 6 years: consult a doctor.
| adults and children 12 years of age and over: | |
| children 6 to under 12 years of age: | 7.5 mL (1/2 TBSP) every 4 hours, not to exceed 45 mL (3 TBSP) per 24 hours |
| children under 6 years: | consult a doctor. |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients citric acid, flavors, glycerin, l-menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum
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
Purpose
Information about the drug product’s indications for use.Purpose Cough Suppressant Expectorant
Spl product data elements
Usually a list of ingredients in a drug product.VANACOF XP Cough / Chest Congestion Dextromethorphan HBr, Guaifenesin GUAIFENESIN GUAIFENESIN SODIUM CITRATE MENTHOL XANTHAN GUM SORBITOL SODIUM BENZOATE ANHYDROUS CITRIC ACID GLYCERIN SUCRALOSE PROPYLENE GLYCOL WATER DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN
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.NDC 58809-187-08 VANACOF® XP COUGH / CHEST CONGESTION Each 15 mL (1 TBSP) contains: Dextromethorphan HBr.....18 mg Guaifenesin ....................396 mg Cough Suppressant ■ Expectorant Raspberry-Mint Flavor Alcohol Free / Sugar Free / Gluten Free / Dye Free VanaCof XP Label
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.Tamper evident by foil seal under cap. Do no use if foil seal is broken or missing. Distributed by: GM Pharmaceuticals, Inc. Fort Worth, TX 76118
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 ■ a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema ■ a cough that occurs with too much phlegm (mucus)
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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 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.
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 ■ each 15 mL (1 TBSP) contains: Sodium 6 mg ■ store at 20° to 30°C (68° to 86°F)
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? 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 ■ cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
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 product do not use more than directed
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.■ store at 20° to 30°C (68° to 86°F)
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 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 ■ a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema ■ a cough that occurs with too much phlegm (mucus) When using this product do not use more than directed Stop use and ask a doctor if ■ cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. 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