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NDC 55505-0111-33 Safetussin 10; 100 mg/5mL; mg/5mL Details
Safetussin 10; 100 mg/5mL; mg/5mL
Safetussin is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Kramer Laboratories. 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: 55505-0111-33Last 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: 55505-0111-33Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin
Product Information
| NDC | 55505-0111 |
|---|---|
| Product ID | 55505-111_5b28bb1e-7b5b-43e5-b36e-f4d2a7db57d7 |
| Associated GPIs | 43997002520910 |
| GCN Sequence Number | 000652 |
| GCN Sequence Number Description | guaifenesin/dextromethorphan LIQUID 100-10MG/5 ORAL |
| HIC3 | B3T |
| HIC3 Description | NON-OPIOID ANTITUSSIVE AND EXPECTORANT COMBINATION |
| GCN | 53491 |
| HICL Sequence Number | 000223 |
| HICL Sequence Number Description | GUAIFENESIN/DEXTROMETHORPHAN HBR |
| Brand/Generic | Generic |
| Proprietary Name | Safetussin |
| Proprietary Name Suffix | DM |
| Non-Proprietary Name | Dextromethorpan Guaifenesin |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 10; 100 |
| Active Ingredient Units | mg/5mL; mg/5mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
| Labeler Name | Kramer Laboratories |
| 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 55505-0111-33 (55505011133)
| NDC Package Code | 55505-111-33 |
|---|---|
| Billing NDC | 55505011133 |
| Package | 1 BOTTLE, PLASTIC in 1 CARTON (55505-111-33) / 118 mL in 1 BOTTLE, PLASTIC |
| Marketing Start Date | 2017-02-10 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |