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NDC 45737-0264-16 Biospec 10; 187 mg/5mL; mg/5mL Details
Biospec 10; 187 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: 45737-0264-16Last 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: 45737-0264-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin
Product Information
NDC | 45737-0264 |
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Product ID | 45737-264_2a2354c5-aee5-4dc9-b397-3d10c72a9b58 |
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 | Biospec |
Proprietary Name Suffix | DMX |
Non-Proprietary Name | Dextromethorphan, Guaifenesin |
Product Type | HUMAN OTC DRUG |
Dosage Form | LIQUID |
Route | ORAL |
Active Ingredient Strength | 10; 187 |
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 45737-0264-16 (45737026416)
NDC Package Code | 45737-264-16 |
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Billing NDC | 45737026416 |
Package | 473 mL in 1 BOTTLE (45737-264-16) |
Marketing Start Date | 2015-03-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL eb29e7cc-e6bb-4b33-88ee-aa3acd6f2970 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
SPL UNCLASSIFIED SECTION
Directions Do not take more than 8 teaspoonfuls in any 24-hour period
adults and children 12 years of age and over | take 2 teaspoonfuls (10 mL) every 4 hours |
children 6 years to under 12 years of age | take 1 teaspoonful every 4 hours |
children 2 years to under 6 years of age | take 1/2 teaspoonful every 4 hours |
children under 2 years of age | consult a doctor |
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
BIOSPEC
DMX
dextromethorphan, guaifenesin liquid |
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Labeler - Advanced Generic Corporation (831762971) |