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| Product NDC Code | 55758-307 | ||||
|---|---|---|---|---|---|
| Drug Name | Sanatos mucus relief cold toddlers |
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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 | ||||
| RxCUI drug identifier | 1020138 | ||||
| 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 ingredients (in each 2.5 mL) Purposes Dextromethorphan HBr 2.5 mg ..... Cough suppressant Guaifenesin 50 mg............ Expectorant
| Dextromethorphan HBr 2.5 mg ..... | |
| Guaifenesin 50 mg............ | Expectorant |
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 give a child more than 6 doses in any 24-hour period repeat the dose every 4 hours measure with the dosing device provided do not use any other dosing device Age Dose children 2 to under 6 years of age 2.5 mL every 4 hours children under 2 years of age ask a doctor
| children 2 to under 6 years of age | 2.5 mL every 4 hours |
| children under 2 years of age | ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients anhydrous citric acid, D&C red #33, dextrose monohydrate, FD&C red #40, flavors, glycerin, maltitol, propylene glycol, purified water, saccharin sodium, sodium benzoate, 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.Use temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to drain the bronchial tubes
Purpose
Information about the drug product’s indications for use.Active ingredients (in each 2.5 mL) Purposes Dextromethorphan HBr 2.5 mg ..... Cough suppressant Guaifenesin 50 mg............ Expectorant
| Dextromethorphan HBr 2.5 mg ..... | |
| Guaifenesin 50 mg............ | Expectorant |
Spl product data elements
Usually a list of ingredients in a drug product.SanaTos Mucus Relief Cold Toddlers Dextromethorphan HBr, Guaifenesin ANHYDROUS CITRIC ACID GLYCERIN PROPYLENE GLYCOL WATER D&C RED NO. 33 DEXTROSE MONOHYDRATE FD&C RED NO. 40 MALTITOL SACCHARIN SODIUM SACCHARIN XANTHAN GUM SUCRALOSE GUAIFENESIN GUAIFENESIN 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.Principal Display Panel Sanatos Toddlers Mucus Relief Cough Dextromethorphan HBr........Cough Suppressant Guaifenesin...............................................Expectorant FOR CHILDREN 2 TO UNDER 6 YEARS Cherry Flavor 2 FL OZ (59 mL) ALCOHOL FREE NON-DROWSY Includes Syringe Sanatos Toddlers
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 the child has cough that is accompanied by excessive phlegm (mucus) or persistent or chronic cough such as occurs with asthma
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 in a child who is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving 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 dose (2.5 mL) contains: sodium 1.5 mg store between 20-25°C (68-77°F) oral dosing device included do not refrigerate Keep carton for full direction for use
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 EST or www.pharmadel.com
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 the child has a cough persists for more than 1 week, tends to recur, or is 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
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 in a child who is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if the child has cough that is accompanied by excessive phlegm (mucus) or persistent or chronic cough such as occurs with asthma When using this product do not use more than directed Stop use and ask a doctor, if the child has a cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. 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