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| Product NDC Code | 73282-0013 | ||||
|---|---|---|---|---|---|
| Drug Name | Drkids childrens cough and chest congestion dm |
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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 | 1020138 | ||||
| Application Number | M012 | ||||
| Labeler Name | CalmCo LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Overdosage of DrKids Childrens Cough and Chest Congestion DM
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient (in each 5mL) Dextromethorphan HBr, USP, 5mg Guaifenesin, USP, 100mg Purpose Cough suppressant 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 more than 6 doses in any 24 hour period give the recommended number of vials below, following the instructions under How to Open and Use on the side panel empty all liquid in each Single-Use Vial when dosing Dosing Char t Age (Years) Dose under 4 years Consult a doctor 4 – 5 years 1 Single-Use Vial (5 mL) every 4 hours 6 – 11 years 1 – 2 Single-Use Vials (5 mL each) every 4 hours Adults and children 12 years and over 2 – 4 Single-Use Vials (5 mL each) every 4 hours
| under 4 years | Consult a doctor |
| 4 – 5 years | 1 Single-Use Vial (5 mL) every 4 hours |
| 6 – 11 years | 1 – 2 Single-Use Vials (5 mL each) every 4 hours |
| Adults and children 12 years and over | 2 – 4 Single-Use Vials (5 mL each) every 4 hours |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients citric acid, glycerin, mixed berry flavor, propylene glycol, purified water, sodium benzoate, sodium saccharin, sorbitol, sucralose, trisodium citrate dihydrate, 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 make cough more productive
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.DrKids Childrens Cough and Chest Congestion DM DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN WATER TRISODIUM CITRATE DIHYDRATE SORBITOL GUAIFENESIN GUAIFENESIN CITRIC ACID MONOHYDRATE SACCHARIN SODIUM SUCRALOSE XANTHAN GUM SODIUM BENZOATE GLYCERIN PROPYLENE GLYCOL
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 PDP
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 your child has persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive 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 your child is 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 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
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information each Single-Use vial contains 6mg of sodium store at 20-25ºC (68-77ºF) tamper evident: do not use if top flap of carton is open. Do not use if any vials are open or broken
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? 941-202-3270 or visit www.DrKids.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 cough lasts for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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 if your child is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if your child has persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus). Stop use and ask a doctor if cough lasts for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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. (1-800-222-1222)
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