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NDC 52083-0630-16 PECGEN DMX 10; 187 mg/5mL; mg/5mL Details
PECGEN DMX 10; 187 mg/5mL; mg/5mL
PECGEN DMX is a ORAL SOLUTION 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: 52083-0630-16Last 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: 52083-0630-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin
Product Information
| NDC | 52083-0630 |
|---|---|
| Product ID | 52083-630_39b9140f-3d5f-47e8-87db-3985a66681c8 |
| Associated GPIs | 43997002520945 |
| GCN Sequence Number | 071484 |
| GCN Sequence Number Description | guaifenesin/dextromethorphan LIQUID 187-10MG/5 ORAL |
| HIC3 | B3T |
| HIC3 Description | NON-OPIOID ANTITUSSIVE AND EXPECTORANT COMBINATION |
| GCN | 35313 |
| HICL Sequence Number | 000223 |
| HICL Sequence Number Description | GUAIFENESIN/DEXTROMETHORPHAN HBR |
| Brand/Generic | Generic |
| Proprietary Name | PECGEN DMX |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Dextromethorphan HBr, Guaifenesin |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 10; 187 |
| Active Ingredient Units | mg/5mL; mg/5mL |
| 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 52083-0630-16 (52083063016)
| NDC Package Code | 52083-630-16 |
|---|---|
| Billing NDC | 52083063016 |
| Package | 474 mL in 1 BOTTLE, PLASTIC (52083-630-16) |
| Marketing Start Date | 2015-04-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL a627824c-5e3d-4672-a047-6c801b50b432 Details
Uses
Warnings
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 your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
• cough that occurs with too much phlegm (mucus)
• a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.
When using this product, do not use more than directed.
Stop use and ask a doctor if
• symptoms do not get better within 7 days or are accompanied by fever
• cough lasts more than 7 days, comes back, 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.
Inactive ingredients
Other information
Questions or comments?
SPL UNCLASSIFIED SECTION
Contains the same active ingredients as Trispec® DMX*
Sugar, Alcohol, Dye and Gluten FREE
CHERRY RASPBERRY FLAVOR
Manufactured in the USA for Kramer Novis
*Trispec® DMX is a registered trademark of Deliz Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Deliz Pharmaceutical Corp.
INGREDIENTS AND APPEARANCE
| PECGEN DMX
dextromethorphan hbr, guaifenesin solution |
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| Labeler - KRAMER NOVIS (090158395) |