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| Product NDC Code | 55758-323 | ||||
|---|---|---|---|---|---|
| Drug Name | Sanatos boost |
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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 | LIQUID | ||||
| Application Number | M012 | ||||
| Labeler Name | Pharmadel 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 & Purposes Active ingredient (in each 20 mL) Purpose Guaifenesin 400 mg............................................... Expectorant Dextromethorphan HBr 20 mg............................... Cough suppressant
| Guaifenesin 400 mg............................................... | Expectorant |
| Dextromethorphan HBr 20 mg............................... | Cough suppressant |
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 exceed recommended dosage use dosage cup mL = milliliter do not take more than 6 doses in any 24-hour period Age Dose adults & children 12 years and older 20 mL every 4 hours children under 12 years of age do not use
| adults & children 12 years and older | 20 mL every 4 hours |
| children under 12 years of age |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients anhydrous citric acid, dextrose, D&C red # 33, FD&C red #40, flavors, glycerin, maltitol, propylene glycol, saccharin sodium, sodium benzoate, sucralose, xanthan gum, water
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 make coughs more productive temporarily relieves common cold/flu symptoms: cough due to minor throat and bronchial irritation
Purpose
Information about the drug product’s indications for use.Active ingredient (in each 20 mL) Purpose Guaifenesin 400 mg............................................... Expectorant Dextromethorphan HBr 20 mg............................... Cough suppressant
| Guaifenesin 400 mg............................................... | Expectorant |
| Dextromethorphan HBr 20 mg............................... | Cough suppressant |
Spl product data elements
Usually a list of ingredients in a drug product.SanaTos Boost DEXTROMETHORPHAN HBR DEXTROSE WATER ANHYDROUS CITRIC ACID SACCHARIN SODIUM DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GLYCERIN FD&C RED NO. 40 MALTITOL PROPYLENE GLYCOL SUCRALOSE SODIUM BENZOATE XANTHAN GUM GUAIFENESIN GUAIFENESIN
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.PACKAGE PRINCIPAL DISPLAY PANEL PDP Boost
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
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 persistent or chronic cough such occurs with smoking, asthma or emphysema trouble urinating due to an enlarged prostate gland
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 for children under 12 years of age 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 two 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.
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? +1-866-359-3478 (M-F) 9 AM to 5 PM Eastern or www.pharmadel.com * This product is not manufactured or distributed by Reckitt Benckiser Inc., distributor of Mucinex® FAST-MAX TM DM MAX
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 a persistent or chronic cough lasts for more than 7 days, tends to recur, or accompanied by fever, rash or persistent headache. 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.Other information each 20 mL contains: sodium 12 mg use provided dosage cup store between 15-30°C (59-86°F) do not refrigerate
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 for children under 12 years of age 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 two 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 persistent or chronic cough such occurs with smoking, asthma or emphysema trouble urinating due to an enlarged prostate gland When using this product do not use more than directed Stop use and ask a doctor if a persistent or chronic cough lasts for more than 7 days, tends to recur, or accompanied by fever, rash or 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