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| Product NDC Code | 59556-850 | ||||
|---|---|---|---|---|---|
| Drug Name | Pediacare childrens cough and congestion |
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| Type | Brand | ||||
| Pharm Class | 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 | part341 | ||||
| Labeler Name | Strides Pharma Inc | ||||
| 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) Dextromehorphan HBr, 5 mg Guaifenesin, 100 mg
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 this product does not contain directions or complete warnings for adult use use only the dosing cup provided do not exceed 6 doses in a 24-hour period mL = milliliter Age (yrs) Dose (ml) under 4 years do not use 4 to under 6 yrs 2.5-5 mL every 4 hours 6 to 11 yrs 5-10 mL every 4 hours
| Age (yrs) | Dose (ml) |
| under 4 years | do not use |
| 4 to under 6 yrs | 2.5-5 mL every 4 hours |
| 6 to 11 yrs | 5-10 mL every 4 hours |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients acesulfame potassium, citric acid, FD&C red no. 33, FD&C red no. 40, flavors, glycerin, monoammonium glycyrrhizinate, poloxamer 407, potassium sorbate, propylene glycol, purified water, sodium chloride, sodium citrate, sucralose, sucrose Questions? 1-888-474-3099 Monday - Friday 8 am to 8 pm EST PediaCare.com
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 rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help your child get to sleep
Purpose
Information about the drug product’s indications for use.Purpose Dextromehorphan HBr, 5 mg…….Cough suppressant Guaifenesin, 100 mg…….………..Expectorant
Spl product data elements
Usually a list of ingredients in a drug product.Pediacare Childrens Cough And Congestion dextromethorphan hydrobromide and guaifenesin DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN CITRIC ACID MONOHYDRATE ACESULFAME POTASSIUM D&C RED NO. 33 FD&C RED NO. 40 GLYCERIN AMMONIUM GLYCYRRHIZATE POLOXAMER 407 POTASSIUM SORBATE PROPYLENE GLYCOL WATER SODIUM CHLORIDE SODIUM CITRATE SUCRALOSE SUCROSE Cherry Flavor
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 PediaCare® Children Cough & Congestion Non Drowsy 4 FL OZ FL (118 mL) Cherry Flavor Carton Container Label - Top Container Label - Base Container Label - Back Carton Container Label - Top Container Label - Base Container Label - Back
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
Other information each 5 mL contains: sodium 3 mg store at room temperature dosage cup provided
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, seek medical help or contact a Poison Control Center (1-800-222-1222) right away.
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 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 occurs with excessive phlegm (mucus) persistent or chronic cough such as occurs with asthma or chronic bronchitis Stop use and ask a doctor if cough gets worse or last more than 7 days cough comes back or occurs with fever, rash, or persistent headache. These could be signs of a serious illness. When using this product do not use more than directed
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