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NDC 52083-0632-16 Presgen 10; 200; 5 mg/5mL; mg/5mL; mg/5mL Details
Presgen 10; 200; 5 mg/5mL; mg/5mL; mg/5mL
Presgen 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: 52083-0632-16Last 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: 52083-0632-16Last 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: 52083-0632-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 52083-0632 |
|---|---|
| Product ID | 52083-632_9e934ca0-f4c9-4e86-9e8d-088fd79f305c |
| Associated GPIs | 43997303100970 |
| GCN Sequence Number | 065638 |
| GCN Sequence Number Description | guaifen/dextromethorphan/PE LIQUID 200-10-5/5 ORAL |
| HIC3 | B4R |
| HIC3 Description | NON-OPIOID ANTITUSSIVE-DECONGESTANT-EXPECTORANT |
| GCN | 27655 |
| HICL Sequence Number | 000216 |
| HICL Sequence Number Description | GUAIFENESIN/DEXTROMETHORPHAN HBR/PHENYLEPHRINE |
| Brand/Generic | Generic |
| Proprietary Name | Presgen |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SYRUP |
| Route | ORAL |
| Active Ingredient Strength | 10; 200; 5 |
| 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], 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 52083-0632-16 (52083063216)
| NDC Package Code | 52083-632-16 |
|---|---|
| Billing NDC | 52083063216 |
| Package | 480 mL in 1 BOTTLE (52083-632-16) |
| Marketing Start Date | 2011-03-28 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL edad7a86-0d27-4a98-85b2-4b6725904f28 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Do Not Use: in a child under 2 years of age
if you are 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 heart disease, thyroid disease, high blood pressure, diabetes
trouble urinating due to enlargement of the prostate gland
cough that occurs with too much phlegm (mucus)
chronic bronchitis or emphysema
When using this product, do not exceed recommended dosage
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 lasts more than 7 days, comes back, or is accompanied by fever,
rash, or persistent headache. These could be signs of a serious condition
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| PRESGEN
guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide syrup |
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| Labeler - Kramer Novis (090158395) |
| Registrant - Kramer Novis (090158395) |