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NDC 00536-1313-85 Chest Congestion Relief 10; 100 mg/5mL; mg/5mL Details
Chest Congestion Relief 10; 100 mg/5mL; mg/5mL
Chest Congestion Relief is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by RUGBY 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: 00536-1313-85Last 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: 00536-1313-85Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin
Product Information
| NDC | 00536-1313 |
|---|---|
| Product ID | 0536-1313_332f30a5-7cd9-4b2b-9938-bb2eb87ed021 |
| 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 | Chest Congestion Relief |
| Proprietary Name Suffix | DM |
| Non-Proprietary Name | Dextromethorphan Hydrobromide, 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 | RUGBY 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 FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00536-1313-85 (00536131385)
| NDC Package Code | 0536-1313-85 |
|---|---|
| Billing NDC | 00536131385 |
| Package | 473 mL in 1 BOTTLE (0536-1313-85) |
| Marketing Start Date | 2020-10-01 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.00709 |
| Pricing Unit | ML |
| Effective Date | 2024-02-21 |
| NDC Description | CHEST CONGESTION RELIEF DM SYR |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
Standard Product Labeling (SPL)/Prescribing Information SPL 60c9e493-f58c-45d6-bade-c95297512403 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
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, 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.
Do not use ifyou have ever had an allergic reaction to any of the ingredients in this product.
Ask a doctor before use if you have
- a cough with too much phlegm (mucus)
- a cough that lasts or is chronic such as occurs with smoking asthma, chronic bronchitis or emphysema.
Stop use and ask a doctor if cough lasts more than 7 days, comes back or is accompanied by fever, rash, or headache that lasts. These could be signs of a serious condition.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| CHEST CONGESTION RELIEF
DM
dextromethorphan hydrobromide, guaifenesin liquid |
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| Labeler - RUGBY LABORATORIES (079246066) |