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NDC 45737-0605-10 Biogtuss 28; 388; 10 mg/1; mg/1; mg/1 Details
Biogtuss 28; 388; 10 mg/1; mg/1; mg/1
Biogtuss is a ORAL TABLET 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: 45737-0605-10Last 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: 45737-0605-10Last 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: 45737-0605-10Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 45737-0605 |
|---|---|
| Product ID | 45737-605_ba0e6be6-75a0-4449-b4cd-3538d17b461c |
| 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 | Biogtuss |
| Proprietary Name Suffix | TR |
| Non-Proprietary Name | Guaifenesin, Phenylephrine HCl, Dextromethorphan HBr |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 28; 388; 10 |
| Active Ingredient Units | mg/1; mg/1; mg/1 |
| 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 45737-0605-10 (45737060510)
| NDC Package Code | 45737-605-10 |
|---|---|
| Billing NDC | 45737060510 |
| Package | 100 TABLET in 1 BOTTLE (45737-605-10) |
| Marketing Start Date | 2014-04-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL bdc5b26f-bb43-4a5e-ac00-5bae1414c3e5 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Uses
Temporarily relieves these symptoms associated with a cough, the common cold, hay fever, or other upper respiratory allergies
- helps loosen phlegm (mucus)
- loosens nasal congestion
- thin bronchial secretions
- drain bronchial tubes
- cough and coughing and calms the cough control center
- make coughs more productive
- clears stuffy nose
- clear nasal passageways
- shrinks swollen membranes
SPL UNCLASSIFIED SECTION
Warnings
Do not exceed recommended dosage
Do not use this product if you are taking a 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 are uncertain whether your prescription drug contains an MAOI, ask a health professional.
Ask a doctor before use if you have:
- heart disease
- excessive phlegm (mucus)
- high blood pressure
- diabetes
- thyroid disease
- difficulty in urination due to enlargement of the prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
When using this product do not use more than directed
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Directions: Do not exceed recommended doses in a 24-hour period
Adults and children 12 years of age and over 1 tablet every 4 hours. Do not exceed 4 tablets in 24 hours
Children 6 to 12 years of age 1/2 tablet every 4 hours. Do not exceed 3 tablets in 24 hours
Children under 6 years of age Ask a doctor
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| BIOGTUSS
TR
guaifenesin, phenylephrine hcl, dextromethorphan hbr tablet |
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| Labeler - Advanced Generic Corporation (831762971) |