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| Product NDC Code | 55758-007 | ||||
|---|---|---|---|---|---|
| Drug Name | Sanatos childrens mucus relief cough |
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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 (in each 5 mL teaspoonful) Purpose Dextromethorphan HBr, USP 5 mg Cough Suppressant Guaifenesin, USP 100 mg Expectorant
| Active Ingredients (in each 5 mL teaspoonful) | Purpose |
|---|---|
| Dextromethorphan HBr, USP 5 mg | Cough Suppressant |
| Guaifenesin, USP 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 take more than 6 doses in any 24-hour period Age Dose Children 6 years to under 12 years 1-2 teaspoonful s (tsps) every 4 hours Children 4 years to under 6 years ½-1 teaspoonful (tsp) every 4 hours Children under 4 years do not use
| Age | Dose |
|---|---|
| Children 6 years to under 12 years | 1-2 teaspoonful s (tsps) every 4 hours |
| Children 4 years to under 6 years | ½-1 teaspoonful (tsp) every 4 hours |
| Children under 4 years | do not use |
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, 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 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 5 mL teaspoonful) Purpose Dextromethorphan HBr, USP 5 mg Cough Suppressant Guaifenesin, USP 100 mg Expectorant
| Active Ingredients (in each 5 mL teaspoonful) | Purpose |
|---|---|
| Dextromethorphan HBr, USP 5 mg | Cough Suppressant |
| Guaifenesin, USP 100 mg | Expectorant |
Spl product data elements
Usually a list of ingredients in a drug product.SanaTos Childrens Mucus Relief Cough DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN ANHYDROUS CITRIC ACID DEXTROSE 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 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.PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton NDC # 55758-007-04 SanaTos ® Children's Mucus Relief COUGH Cherry Flavor Dextromethorphan HBr Cough Suppressant Guafenesin Expectorant Relieves Chest Congestion Thins & Loosens Mucus Alcohol-Free For Ages 4 to 12 4 FL OZ (118 mL) PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
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 ® Seaford, DE 19973
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 id the child has cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma
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 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? Call weekdays from 9:30 AM to 4:30 PM EST 1-877-798-5944
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 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
Storage and handling
Information about safe storage and handling of the drug product.Other information each teaspoon contains: sodium 3 mg store between 20-25 C (68-77 F) do not refrigerate dosage cup provided Keep cartoon for full directions for 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 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 id the child has cough that occurs with too much phlegm (mucus) 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 cough lasts more than 7 days, comes back or occurs with 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 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