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NDC 63187-0853-04 good sense tussin dm 20; 200 mg/10mL; mg/10mL Details
good sense tussin dm 20; 200 mg/10mL; mg/10mL
good sense tussin dm is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. 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: 63187-0853-04Last Updated: 12/01/2022
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: 63187-0853-04Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin
Product Information
| NDC | 63187-0853 |
|---|---|
| Product ID | 63187-853_d216e267-eb95-41dd-9bc3-5ae4d99383f9 |
| Associated GPIs | |
| 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 | good sense tussin dm |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Dextromethorphan Hydrobromide, Guaifenesin |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 20; 200 |
| Active Ingredient Units | mg/10mL; mg/10mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
| Labeler Name | Proficient Rx LP |
| 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 63187-0853-04 (63187085304)
| NDC Package Code | 63187-853-04 |
|---|---|
| Billing NDC | 63187085304 |
| Package | 1 BOTTLE in 1 CARTON (63187-853-04) / 118 mL in 1 BOTTLE |
| Marketing Start Date | 2017-06-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 4901f25c-96a7-4fe3-b7d3-e1cebeabd803 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)
- •
- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
Directions
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- do not take more than 6 doses in any 24-hour period
- •
- measure only with dosing cup provided
- •
- keep dosing cup with product
- •
- mL = milliliter
- •
- this adult product is not intended for use in children under 12 years of age
|
age |
dose |
|
adults and children 12 years and over |
10 mL every 4 hours |
|
children under 12 years |
do not use |
Other information
Inactive ingredients
Principal Display Panel
INGREDIENTS AND APPEARANCE
| GOOD SENSE TUSSIN DM
dextromethorphan hydrobromide, guaifenesin solution |
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| Labeler - Proficient Rx LP (079196022) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Proficient Rx LP | 079196022 | RELABEL(63187-853) | |