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NDC 53809-0250-04 DOMETUSS-G 20; 200; 10 mg/1; mg/1; mg/1 Details
DOMETUSS-G 20; 200; 10 mg/1; mg/1; mg/1
DOMETUSS-G is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by DOMEL. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE.
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: 53809-0250-04Last 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: 53809-0250-04Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
Related Packages: 53809-0250-04Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 53809-0250 |
|---|---|
| Product ID | 53809-250_dc4a9eb6-1eb6-46ed-b51d-ef80ec05e694 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | DOMETUSS-G |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 20; 200; 10 |
| Active Ingredient Units | mg/1; mg/1; mg/1 |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | DOMEL |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 53809-0250-04 (53809025004)
| NDC Package Code | 53809-250-04 |
|---|---|
| Billing NDC | 53809025004 |
| Package | 4 TABLET in 1 BOTTLE (53809-250-04) |
| Marketing Start Date | 2019-11-11 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 19e06e4d-9efb-4059-a33d-4a89c3a2534c Details
SPL UNCLASSIFIED SECTION
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
- temporarily reduces cough due to minor throat and bronchial irritation associated with a cold
- calm the cough control center, and relieves coughing.
- Temporarily relief nasal congestion due to the common cold
- hay fever or other upper respiratory allergies
- sinus congestion and pressure
Warnings
- Do not exceed recommended dosage
If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor.
Do not use
- if you are now taken a prescription Monoaminoxidase Inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions or Parkinson's disease), or for two weeks after stopping the MAOI drug; If you do not know if you are taking a prescription drug that contains an MAOI, ask a doctor or pharmacist before taking this product
Do not take this product: for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor.
Do not give this product if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.
Ask a doctor before use if you have
- liver disease
- if you are taking the blood thinning drug warfarin.
Directions
Other information
Inactive ingredients
Questions or comments?
PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
INGREDIENTS AND APPEARANCE
| DOMETUSS-G
guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochloride tablet |
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| Labeler - DOMEL (808198837) |