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| Product NDC Code | 45737-230 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Bio-s-pres dx |
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| Type | Brand | ||||||
| Pharm Class | Adrenergic alpha1-Agonists [MoA], 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 | SOLUTION/ DROPS | ||||||
| RxCUI drug identifier | 1095503 | ||||||
| Application Number | part341 | ||||||
| Labeler Name | Advanced Generic Corporation | ||||||
| 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 1mL) Purpose Dextromethorphan HBr, 5 mg ................................. Cough Suppressant Guaifenesin, 50 mg ................................................ Expectorant Phenylephrine HCl, 2.5 mg ...................................... Nasal Decongestant
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 exceed more than 6 doses in any 24-hour period. Measure with the dosage device provided. Do not use with any other device. Age Dose Children 2 to under 6 years of age 1 mL every 4 hours Children under 2 years of age Consult a doctor
| Age | Dose |
| Children 2 to under 6 years of age | 1 mL every 4 hours |
| Children under 2 years of age | Consult a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Artificial and natural Cherry Flavor, Citric Acid, FD and C Red No. 40, Glycerin, Methyl Paraben (as preservative), Propylene Glycol, Propylparaben (as preservative), Purified Water, sodium citrate, 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) and 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.Purpose Cough Suppressant Expectorant Nasal Decongestant
Spl product data elements
Usually a list of ingredients in a drug product.Bio-S-Pres DX Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl CITRIC ACID MONOHYDRATE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID FD&C RED NO. 40 GLYCERIN METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE SUCRALOSE 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.biospres
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 this product: for persistent or chronic cough such as occurs with asthma, or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor. in a child who is taking a prescription Monoaminooxidase 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. Do not give this product to child who has heart disease, high blood pressure, thyroid disease, or diabetes, unless directed by a doctor. Stop use and ask a doctor: A persistent cough may be a sign of a serious condition; If cough persists for more than one week, tend to recur, or is accompanied by fever, rash or persistent headache, consult a doctor.
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 the 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? 1-305-403-3788
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 exceed recommended dosage. If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor. If symptoms do not improve within 7 days or accompanied by fever, consult a doctor.
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