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| Product NDC Code | 55758-013 | ||||
|---|---|---|---|---|---|
| Drug Name | Sanatos children cough and congestion cherry |
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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 teaspoonful, 5 mL) Purposes Dextromethorphan HBr 5 mg ..... Cough Suppressant Guaifenesin 100 mg ..... Expectorant
| Dextromethorphan HBr 5 mg ..... | Cough Suppressant |
| Guaifenesin 100 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 Age Dose Children 6 to under 12 years of age 1-2 teaspoonfuls (tsps) every 4 hours Children 2 to under 6 years of age ½-1 teaspoonful (tsp) every 4 hours Children under 2 years of age consult a doctor
| Age | Dose |
|---|---|
| Children 6 to under 12 years of age | 1-2 teaspoonfuls (tsps) every 4 hours |
| Children 2 to under 6 years of age | ½-1 teaspoonful (tsp) every 4 hours |
| Children under 2 years of age | consult 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.Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common 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 teaspoonful, 5 mL) Purposes Dextromethorphan HBr 5 mg ..... Cough Suppressant Guaifenesin 100 mg ..... Expectorant
| Dextromethorphan HBr 5 mg ..... | Cough Suppressant |
| Guaifenesin 100 mg ..... | Expectorant |
Spl product data elements
Usually a list of ingredients in a drug product.SanaTos Children Cough and Congestion Cherry DEXTROMETHORPHAN HBr and GUAIFENESIN GUAIFENESIN GUAIFENESIN ANHYDROUS CITRIC ACID DEXTROSE MONOHYDRATE D&C RED NO. 33 FD&C RED NO. 40 GLYCERIN MALTITOL PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM BENZOATE SUCRALOSE XANTHAN GUM 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 Saantos Children CC
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
Distributed by: PHARMDEL LLC New Castle, DE 19720
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 a cough that is accompanied by excessive phlegm (mucus) 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 per teaspoonful (5mL) contains: 3mg Sodium store at 20- 25º C (68- 77º F) do not refrigerate dosage cup included TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 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 that lasts more than 7 days, tends to recur, or is accompanied by fever, rash or a persistent headache. These could be signs of a serious condition.
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 a cough that is accompanied by excessive phlegm (mucus) persistent or chronic cough such as occurs with asthma Stop use and ask a doctor, if the child has a cough that lasts more than 7 days, tends to recur, or is accompanied by fever, rash or a 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