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NDC 00121-0638-00 GUAIFENESIN DM 10; 100 mg/5mL; mg/5mL Details
GUAIFENESIN DM 10; 100 mg/5mL; mg/5mL
GUAIFENESIN DM is a ORAL SYRUP in the HUMAN OTC DRUG category. It is labeled and distributed by PAI Holdings, LLC. The primary component is DEXTROMETHORPHAN; 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: 00121-0638-00Last 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: 00121-0638-00Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin
Product Information
| NDC | 00121-0638 |
|---|---|
| Product ID | 0121-0638_91dc8d9b-2cb4-4a03-a984-a8b921ddd967 |
| Associated GPIs | 43997002521220 |
| GCN Sequence Number | 016414 |
| GCN Sequence Number Description | guaifenesin/dextromethorphan SYRUP 100-10MG/5 ORAL |
| HIC3 | B3T |
| HIC3 Description | NON-OPIOID ANTITUSSIVE AND EXPECTORANT COMBINATION |
| GCN | 53495 |
| HICL Sequence Number | 000223 |
| HICL Sequence Number Description | GUAIFENESIN/DEXTROMETHORPHAN HBR |
| Brand/Generic | Generic |
| Proprietary Name | GUAIFENESIN DM |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | GUAIFENESIN and DEXTROMETHORPHAN |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SYRUP |
| Route | ORAL |
| Active Ingredient Strength | 10; 100 |
| Active Ingredient Units | mg/5mL; mg/5mL |
| Substance Name | DEXTROMETHORPHAN; GUAIFENESIN |
| Labeler Name | PAI Holdings, LLC |
| Pharmaceutical Class | Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Ant |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH DRUG |
| Application Number | M012 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00121-0638-00 (00121063800)
| NDC Package Code | 0121-0638-00 |
|---|---|
| Billing NDC | 00121063800 |
| Package | 10 TRAY in 1 CASE (0121-0638-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0638-05) |
| Marketing Start Date | 1992-07-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |