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NDC 45737-0211-16 Biospec 15; 25 mg/5mL; mg/5mL Details
Biospec 15; 25 mg/5mL; mg/5mL
Biospec 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.
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: 45737-0211-16Last 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: 45737-0211-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin
Product Information
| NDC | 45737-0211 |
|---|---|
| Product ID | 45737-211_5c91244c-f997-481e-b9f2-b2814efc6e7d |
| Associated GPIs | 43997002520913 |
| GCN Sequence Number | 058203 |
| GCN Sequence Number Description | guaifenesin/dextromethorphan LIQUID 25-15MG/5 ORAL |
| HIC3 | B3T |
| HIC3 Description | NON-OPIOID ANTITUSSIVE AND EXPECTORANT COMBINATION |
| GCN | 23562 |
| HICL Sequence Number | 000223 |
| HICL Sequence Number Description | GUAIFENESIN/DEXTROMETHORPHAN HBR |
| Brand/Generic | Generic |
| Proprietary Name | Biospec |
| Proprietary Name Suffix | DMX |
| Non-Proprietary Name | Dextromethorphan, Guaifenesin |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 15; 25 |
| Active Ingredient Units | mg/5mL; mg/5mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
| Labeler Name | Advanced Generic Corporation |
| Pharmaceutical Class | Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 45737-0211-16 (45737021116)
| NDC Package Code | 45737-211-16 |
|---|---|
| Billing NDC | 45737021116 |
| Package | 473 mL in 1 BOTTLE (45737-211-16) |
| Marketing Start Date | 2009-10-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 54fcf605-39e9-47dd-ada4-1c4749af8dd8 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
- Do not exceed recommended dosage.
- Do not use 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 your doctor or pharmacist before taking this product.
- Cough that occurs with too much phlegm (mucus)
- Cough that lasts or is such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Directions Do not take more than 6 doses in any 24-hour period, unless directed by a physician
adults and children 12 years and over, 1 teaspoonfuls (5 ml) every 4 hours
children 6 years to under 12 years, 1/2 teaspoonful (2.5 ml) every 4 hours
children 4 to 6 years, 1/4 teaspoonful (1.25 ml) every 4 hours
children under 4 years of age, consult a doctor
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| BIOSPEC
DMX
dextromethorphan, guaifenesin liquid |
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| Labeler - Advanced Generic Corporation (831762971) |