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NDC 52083-0678-16 G-TRON 15; 350; 10 mg/5mL; mg/5mL; mg/5mL Details
G-TRON 15; 350; 10 mg/5mL; mg/5mL; mg/5mL
G-TRON 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; 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: 52083-0678-16Last 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: 52083-0678-16Last 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: 52083-0678-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 52083-0678 |
|---|---|
| Product ID | 52083-678_7d8d222b-b7a2-4165-b432-d400969ec490 |
| Associated GPIs | 43997303100976 |
| GCN Sequence Number | 050338 |
| GCN Sequence Number Description | guaifen/dextromethorphan/PE LIQUID 350-15-10 ORAL |
| HIC3 | B4R |
| HIC3 Description | NON-OPIOID ANTITUSSIVE-DECONGESTANT-EXPECTORANT |
| GCN | 17345 |
| HICL Sequence Number | 000216 |
| HICL Sequence Number Description | GUAIFENESIN/DEXTROMETHORPHAN HBR/PHENYLEPHRINE |
| Brand/Generic | Generic |
| Proprietary Name | G-TRON |
| Proprietary Name Suffix | PED |
| Non-Proprietary Name | Dextromethorphan Hbr, Guiafenesin, Phenylephrine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 15; 350; 10 |
| Active Ingredient Units | mg/5mL; mg/5mL; mg/5mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | Kramer Novis |
| 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 52083-0678-16 (52083067816)
| NDC Package Code | 52083-678-16 |
|---|---|
| Billing NDC | 52083067816 |
| Package | 474 mL in 1 BOTTLE (52083-678-16) |
| Marketing Start Date | 2014-01-27 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 75cd3241-e571-4b50-b03a-1715dc747825 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
- suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes, and make coughs more productive
- temporarily relieves nasal congestion due to a cold
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), 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.
SPL UNCLASSIFIED SECTION
Ask a doctor before use if you have
- diabetes
- heart disease
- thyroid disease
- high blood pressure
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- 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
- you get nervous, dizzy or sleepless
- symptoms do not get better within 7 days or are accompanied by fever
- cough last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be a signs of a serious condition.
SPL UNCLASSIFIED SECTION
Directions
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Principal Display Panel
INGREDIENTS AND APPEARANCE
| G-TRON
PED
dextromethorphan hbr, guiafenesin, phenylephrine hcl solution |
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| Labeler - Kramer Novis (090158395) |