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NDC 45737-0208-16 Biocotron-D 10; 200; 5 mg/5mL; mg/5mL; mg/5mL Details
Biocotron-D 10; 200; 5 mg/5mL; mg/5mL; mg/5mL
Biocotron-D is a ORAL SUSPENSION/ DROPS 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: 45737-0208-16Last 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: 45737-0208-16Last 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: 45737-0208-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 45737-0208 |
|---|---|
| Product ID | 45737-208_09f2b66a-cbe2-4baf-a9a6-a55f0426cdd7 |
| Associated GPIs | |
| GCN Sequence Number | 065638 |
| GCN Sequence Number Description | guaifen/dextromethorphan/PE LIQUID 200-10-5/5 ORAL |
| HIC3 | B4R |
| HIC3 Description | NON-OPIOID ANTITUSSIVE-DECONGESTANT-EXPECTORANT |
| GCN | 27655 |
| HICL Sequence Number | 000216 |
| HICL Sequence Number Description | GUAIFENESIN/DEXTROMETHORPHAN HBR/PHENYLEPHRINE |
| Brand/Generic | Brand |
| Proprietary Name | Biocotron-D |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SUSPENSION/ DROPS |
| Route | ORAL |
| Active Ingredient Strength | 10; 200; 5 |
| 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 45737-0208-16 (45737020816)
| NDC Package Code | 45737-208-16 |
|---|---|
| Billing NDC | 45737020816 |
| Package | 473 mL in 1 BOTTLE (45737-208-16) |
| Marketing Start Date | 2013-03-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL d1da2b49-af3a-4b80-a62c-c9147dab3113 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Warnings:
Ask a doctor before use if you have:Heart disease, high blood pressure, thyroid disease, diabetes, trouble urinating due to an enlarged prostate gland, cough that last or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.
Ask doctor or pharmacist before use if you are taking any other nasal decongestant or stimulant.
When using this product do not use more than directed.
SPL UNCLASSIFIED SECTION
If you are now 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 you are taking a prescription drug that contains an MAOI, ask a doctor or pharmacist before taking this product.
Stop use and ask a doctor before use if:
- you get nervous, dizzy or sleepless; symptoms do not get better within 7 or are accompanied by fever
- cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Directions: Do not take more than 3 doses in any 24-hour period.
| Age | Dose |
| Adults and children 12 years of age and over | 2 teaspoons every 4 hours |
| Children 6 to under 12 years of age | 1 teaspoon every 4 hours |
| Children 2 to under 6 years of age | 1/2 teaspoon every 4 hours |
| Children under 2 years of age | Ask a doctor |
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| BIOCOTRON-D
dextromethorphan hbr, guaifenesin, phenylephrine hcl suspension/ drops |
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| Labeler - Advanced Generic Corporation (831762971) |