Search by Drug Name or NDC
NDC 45737-0263-16 Biodesp 15; 100; 5 mg/5mL; mg/5mL; mg/5mL Details
Biodesp 15; 100; 5 mg/5mL; mg/5mL; mg/5mL
Biodesp 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.
Product Information
| NDC | 45737-0263 |
|---|---|
| Product ID | 45737-263_01e61e17-30cb-4c85-a365-b1d68514c06f |
| 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 | Biodesp |
| Proprietary Name Suffix | DM NF |
| Non-Proprietary Name | Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 15; 100; 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 45737-0263-16 (45737026316)
| NDC Package Code | 45737-263-16 |
|---|---|
| Billing NDC | 45737026316 |
| Package | 473 mL in 1 BOTTLE (45737-263-16) |
| Marketing Start Date | 2015-03-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 82528dba-e3e7-416a-935d-7b6324a83f5a Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Uses
- temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis), or other upper respiratory allergies:
- cough due to minor throat and bronchial irritation
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
- nasal congestion
- reduces swelling of nasal passages
SPL UNCLASSIFIED SECTION
Warnings:
Do no exceed recommended dosage
- A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur or is accompanied by a fever, rash or a persistent headache, consult 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 a doctor 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 unless directed by a doctor
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
Directions: take every 4 hours, not to exceed 6 doses in 24 hours or as directed by a doctor.
| Age | Dose |
| Adults and children 12 years of age and over | 2 teaspoonfuls (10 mL) every 4 hours |
| Children 6 to under 12 years of age | 1 teaspoonful (5 mL) every 4 hours |
| Children under 6 years of age | 1/2 teaspoonful (2.5 mL) every 4 hours to consult a doctor |
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| BIODESP
DM NF
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid |
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
| Labeler - Advanced Generic Corporation (831762971) |
Revised: 12/2020
Document Id: 01e61e17-30cb-4c85-a365-b1d68514c06f
Set id: 82528dba-e3e7-416a-935d-7b6324a83f5a
Version: 5
Effective Time: 20201223