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NDC 45737-0261-16 Biocotron 15; 350; 10 mg/5mL; mg/5mL; mg/5mL Details
Biocotron 15; 350; 10 mg/5mL; mg/5mL; mg/5mL
Biocotron is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Advanced Generic Corporation. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
Related Packages: 45737-0261-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan
Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.
Related Packages: 45737-0261-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
Related Packages: 45737-0261-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 45737-0261 |
|---|---|
| Product ID | 45737-261_465fc4d2-eac7-4b1e-9096-9b2d4f5851fc |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Biocotron |
| Proprietary Name Suffix | PED |
| Non-Proprietary Name | Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 15; 350; 10 |
| Active Ingredient Units | mg/5mL; mg/5mL; mg/5mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | Advanced Generic Corporation |
| Pharmaceutical 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] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 45737-0261-16 (45737026116)
| NDC Package Code | 45737-261-16 |
|---|---|
| Billing NDC | 45737026116 |
| Package | 473 mL in 1 BOTTLE (45737-261-16) |
| Marketing Start Date | 2015-03-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 53097e28-ff2a-4ceb-9c95-d75d7ae511b8 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Uses
- non-narcotic cough suppressant which temporarily calms cough due to minor throat and bronchial irritation as may occur with the common cold
- calms the cough control center and relieves coughing
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive.
- temporarily relieves nasal congestion due to the common cold
- helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure
SPL UNCLASSIFIED SECTION
Warnings:
Do no exceed recommended dosage
a persistent cough may be a sign of a serious condition. If cough persist for more than 1 week, tends to recur, or is accompanied by fever, rash or a persistent headache, constult a doctor
Do not use this product if you
are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional condition. or for two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a MAOI, ask a doctor or phamacist before taking thie product.
Ask doctor or pharmacist before use if you have
- a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
- high blood pressure
- heart disease
- thyroid disease
- diabetes
- difficulty in urincation due to enlargment of the prostate gland
Stop use and ask a doctor if:
- nervousness, dizziness, or sleeplessness occur.
- if symptoms do not improve within 7 days or are accompanied by fever
Ask a doctor before use if you are taking sedatives or tranquilizers.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| BIOCOTRON
PED
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid |
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| Labeler - Advanced Generic Corporation (831762971) |