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NDC 52083-0655-01 G-Supress DX 5; 50; 2.5 mg/mL; mg/mL; mg/mL Details
G-Supress DX 5; 50; 2.5 mg/mL; mg/mL; mg/mL
G-Supress DX is a ORAL SYRUP 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: 52083-0655-01Last 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: 52083-0655-01Last 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: 52083-0655-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 52083-0655 |
|---|---|
| Product ID | 52083-655_a7a9c734-51f2-4396-bad0-0da368adcd75 |
| Associated GPIs | 43997303100940 |
| GCN Sequence Number | 040290 |
| GCN Sequence Number Description | guaifen/dextromethorphan/PE DROPS 50-5-2.5/1 ORAL |
| HIC3 | B4R |
| HIC3 Description | NON-OPIOID ANTITUSSIVE-DECONGESTANT-EXPECTORANT |
| GCN | 53092 |
| HICL Sequence Number | 000216 |
| HICL Sequence Number Description | GUAIFENESIN/DEXTROMETHORPHAN HBR/PHENYLEPHRINE |
| Brand/Generic | Brand |
| Proprietary Name | G-Supress DX |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SYRUP |
| Route | ORAL |
| Active Ingredient Strength | 5; 50; 2.5 |
| Active Ingredient Units | mg/mL; mg/mL; mg/mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | KRAMER NOVIS |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], 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 |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 52083-0655-01 (52083065501)
| NDC Package Code | 52083-655-01 |
|---|---|
| Billing NDC | 52083065501 |
| Package | 30 mL in 1 BOTTLE (52083-655-01) |
| Marketing Start Date | 2011-03-29 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 5dd44337-f3aa-4e73-a206-4a29850a2f7c Details
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
- temporarily relieves:
• nasal congestion due to hay fever or other upper respiratory allergies (allergic rhinitis)
• cough due to minor throat and bronchial irritation as may occur with the common cold
Warnings
Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Ask a doctor before use if the child has
• heart disease • thyroid disease • high blood pressure
• diabetes
• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with asthma
When using this product do not exceed recommended dosage.
Stop use and ask a doctor if
• your child gets nervous, dizzy, or sleepless
• 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.
Directions
Other information
Inactive Ingredients
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| G-SUPRESS DX
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride syrup |
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| Labeler - KRAMER NOVIS (090158395) |
| Registrant - KRAMER NOVIS (090158395) |