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NDC 52083-0058-01 Supress DM 5; 50 mg/mL; mg/mL Details
Supress DM 5; 50 mg/mL; mg/mL
Supress DM is a ORAL SYRUP in the HUMAN OTC DRUG category. It is labeled and distributed by KRAMER NOVIS. 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: 52083-0058-01Last 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: 52083-0058-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin
Product Information
| NDC | 52083-0058 |
|---|---|
| Product ID | 52083-058_584d5e8d-618d-4451-9c23-897f64b3e34c |
| Associated GPIs | 43997002520929 |
| GCN Sequence Number | 071551 |
| GCN Sequence Number Description | guaifenesin/dextromethorphan DROPS 50-5MG/ML ORAL |
| HIC3 | B3T |
| HIC3 Description | NON-OPIOID ANTITUSSIVE AND EXPECTORANT COMBINATION |
| GCN | 35413 |
| HICL Sequence Number | 000223 |
| HICL Sequence Number Description | GUAIFENESIN/DEXTROMETHORPHAN HBR |
| Brand/Generic | Brand |
| Proprietary Name | Supress DM |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | dextromethorphan hydrobromide, guaifenesin |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SYRUP |
| Route | ORAL |
| Active Ingredient Strength | 5; 50 |
| Active Ingredient Units | mg/mL; mg/mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
| Labeler Name | KRAMER NOVIS |
| 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 52083-0058-01 (52083005801)
| NDC Package Code | 52083-058-01 |
|---|---|
| Billing NDC | 52083005801 |
| Package | 30 mL in 1 BOTTLE (52083-058-01) |
| Marketing Start Date | 2013-10-02 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 7da0611e-729c-4cf8-88f3-f8877b9f5cfa Details
Uses
Warnings
Do not use:
in a child who is 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 your child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if your child has
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with asthma.
When using this product do not exceed the recommended dosage.
Stop use and ask a doctor if
- new symptoms occur
- coughs persists for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Directions
Inactive ingredients
Other information
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| SUPRESS DM
dextromethorphan hydrobromide, guaifenesin syrup |
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| Labeler - KRAMER NOVIS (090158395) |
| Registrant - KRAMER NOVIS (090158395) |