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NDC 58657-0500-16 Codeine-Guaifenesin 10; 100 mg/5mL; mg/5mL Details
Codeine-Guaifenesin 10; 100 mg/5mL; mg/5mL
Codeine-Guaifenesin is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Method Pharmaceuticals, LLC. The primary component is CODEINE PHOSPHATE; GUAIFENESIN.
MedlinePlus Drug Summary
Codeine is used to relieve mild to moderate pain. It is also used, usually in combination with other medications, to reduce coughing. Codeine will help relieve symptoms but will not treat the cause of symptoms or speed recovery. Codeine belongs to a class of medications called opiate (narcotic) analgesics and to a class of medications called antitussives. When codeine is used to treat pain, it works by changing the way the brain and nervous system respond to pain. When codeine is used to reduce coughing, it works by decreasing the activity in the part of the brain that causes coughing. Codeine is also available in combination with acetaminophen (Capital and Codeine, Tylenol with Codeine), aspirin, carisoprodol, and promethazine and as an ingredient in many cough and cold medications. This monograph only includes information about the use of codeine. If you are taking a codeine combination product, be sure to read information about all the ingredients in the product you are taking and ask your doctor or pharmacist for more information.
Related Packages: 58657-0500-16Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Codeine
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: 58657-0500-16Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin
Product Information
| NDC | 58657-0500 |
|---|---|
| Product ID | 58657-500_0c5a0409-72fe-dd9b-e063-6394a90ae6a7 |
| Associated GPIs | 43997002282020 |
| GCN Sequence Number | 045669 |
| GCN Sequence Number Description | codeine phosphate/guaifenesin LIQUID 10-100MG/5 ORAL |
| HIC3 | B4S |
| HIC3 Description | OPIOID ANTITUSSIVE-EXPECTORANT COMBINATION |
| GCN | 91713 |
| HICL Sequence Number | 000206 |
| HICL Sequence Number Description | CODEINE PHOSPHATE/GUAIFENESIN |
| Brand/Generic | Generic |
| Proprietary Name | Codeine-Guaifenesin |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Codeine Phosphate and Guaifenesin |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 10; 100 |
| Active Ingredient Units | mg/5mL; mg/5mL |
| Substance Name | CODEINE PHOSPHATE; GUAIFENESIN |
| Labeler Name | Method Pharmaceuticals, LLC |
| Pharmaceutical Class | Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Full Opioid Agonists [MoA], Increased Respiratory Secretions [PE], Opioid Agonist [EPC] |
| DEA Schedule | CV |
| Marketing Category | OTC MONOGRAPH DRUG |
| Application Number | M012 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 58657-0500-16 (58657050016)
| NDC Package Code | 58657-500-16 |
|---|---|
| Billing NDC | 58657050016 |
| Package | 473 mL in 1 BOTTLE (58657-500-16) |
| Marketing Start Date | 2014-04-01 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.03653 |
| Pricing Unit | ML |
| Effective Date | 2024-02-21 |
| NDC Description | CODEINE-GUAIFEN 10-100 MG/5 ML |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |