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| Product NDC Code | 52083-055 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Supress dx pediatric drops |
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| Type | Brand | ||||||
| Pharm Class | Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | SYRUP | ||||||
| RxCUI drug identifier | 1095503 | ||||||
| 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, 5mg Guaifenesin, 50mg Phenylephrine HCl, 2.5mg
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 use more than 6 doses in any 24-hour period • repeat every 4 hours • measure with the dosage device provided. Do not use with any other device • children 2 to under 6 years of age: 1 mL • children under 2 years of age: Consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients • Citric acid, FD&C Red 40, Flavor, Glycerin, Methylparaben, Propylene Glycol, Propylparaben, Purified Water and Sucralose.
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 drain bronchial tubes and make coughs more productive • temporarily relieves: • nasal congestion due to hay fever or other upper respiratory allergies (allergic rhinitis) • cough due to minor throat and bronchial irritation as may occur with the common cold
Purpose
Information about the drug product’s indications for use.Purposes Cough Suppressant Expectorant Nasal Decongestant
Spl product data elements
Usually a list of ingredients in a drug product.Supress DX Pediatric Drops Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride GUAIFENESIN GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CITRIC ACID MONOHYDRATE FD&C RED NO. 40 GLYCERIN METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SUCRALOSE SOUR CHERRY CHERRY RED
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 SupresDX
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
Sugar & Alcohol Free Kramer Novis Pharmaceuticals within reach of patients Manufactured in the USA for Kramer Novis, San Juan, PR 00917. www.kramernovis.com RETAIN CARTON FOR FULL PRESCRIBING INFORMATION
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.
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? call weekdays from 8 am to 4 pm AST at 1.787.767.2072
Storage and handling
Information about safe storage and handling of the drug product.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)
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 • 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