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| Product NDC Code | 52083-058 | ||||
|---|---|---|---|---|---|
| Drug Name | Supress dm |
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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 | SYRUP | ||||
| RxCUI drug identifier | 1439992 | ||||
| Application Number | part341 | ||||
| Labeler Name | KRAMER NOVIS | ||||
| 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 1 ml) Dextromethorphan HBr, 5 mg Guaifenesin, 50 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 Children 6 to under 12 years of age • 1 mL every 4 hours as needed, do not exceed 6 doses in any 24-hour, or as directed by a doctor • Children under 6, consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Citric acid, flavor, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate and sodium saccharin.
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 controls cough due to minor throat and bronchial irritation as may occur with a cold • Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus, drain bronchial tubes, and make coughs 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.Supress DM dextromethorphan hydrobromide, guaifenesin GUAIFENESIN GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN CITRIC ACID MONOHYDRATE GLYCERIN METHYLPARABEN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE, UNSPECIFIED FORM SACCHARIN SODIUM SWEET CHERRY
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.Packaging image description
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
COUGH SUPRESSANT EXPECTORANT No sugar, dye, alcohol, aspartame or sorbitol DECONGESTANT FREE Manufacture in the USA for Kramer-Novis, San Juan, PR 00917. Tel: (787) 767-2072 www.kramernovis.com
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 accidental 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 • Tamper Evident Feature: Do not use if cap seal is torn, broken or missing. • Store at controlled room temperature 15°-30°C (59°-86°F). • Avoid excessive heat and humidity.
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 taking this product. Ask a doctor before use if your child has cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with asthma. When using this product do not exceed the recommended dosage. Stop use and ask a doctor if new symptoms occur coughs 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children . In case of accidental 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