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NDC 52083-0637-16 Presgen B 4; 20; 10 mg/5mL; mg/5mL; mg/5mL Details
Presgen B 4; 20; 10 mg/5mL; mg/5mL; mg/5mL
Presgen B is a ORAL SYRUP in the HUMAN OTC DRUG category. It is labeled and distributed by KRAMER NOVIS. The primary component is BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Brompheniramine relieves red, irritated, itchy, watery eyes; sneezing; and runny nose caused by allergies, hay fever, and the common cold. Brompheniramine helps control symptoms, but does not treat the cause of the symptoms or speed recovery. Brompheniramine should not be used to cause sleepiness in children. Brompheniramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
Related Packages: 52083-0637-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Brompheniramine
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: 52083-0637-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan
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: 52083-0637-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 52083-0637 |
|---|---|
| Product ID | 52083-637_8d67304c-5718-4e3f-be6b-b5d920f442b2 |
| Associated GPIs | 43995803080940 |
| GCN Sequence Number | 051165 |
| GCN Sequence Number Description | brompheniram/phenylephrine/DM LIQUID 4-10-20/5 ORAL |
| HIC3 | B3R |
| HIC3 Description | NON-OPIOID ANTITUS-1ST GEN.ANTIHISTAMINE-DECONGEST |
| GCN | 18314 |
| HICL Sequence Number | 035368 |
| HICL Sequence Number Description | BROMPHENIRAMINE MALEATE/PHENYLEPHRINE HCL/DEXTROMETHORPHAN |
| Brand/Generic | Generic |
| Proprietary Name | Presgen B |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | dextromethorphan hydrobromide, brompheniramine maleate, phenylephrine hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SYRUP |
| Route | ORAL |
| Active Ingredient Strength | 4; 20; 10 |
| Active Ingredient Units | mg/5mL; mg/5mL; mg/5mL |
| Substance Name | BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; 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 52083-0637-16 (52083063716)
| NDC Package Code | 52083-637-16 |
|---|---|
| Billing NDC | 52083063716 |
| Package | 480 mL in 1 BOTTLE (52083-637-16) |
| Marketing Start Date | 2011-03-29 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 5befa829-32bd-4978-8a0e-1d6513ff37a4 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Uses: Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • sneezing • itchy nose or throat • runny nose • itchy, watery eyes • nasal congestion • temporarily controls cough due to minor throat and bronchial irritation associated with inhaled irritants • temporarily restores freer breathing through nose
SPL UNCLASSIFIED SECTION
Warnings: 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 • high blood pressure • thyroid disease • diabetes • glaucoma • cough that occurs with too much phlegm (mucus) • trouble urinating due to an enlarged prostate gland • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema. Do not give this product to children who have breathing problems such as chronic bronchitis or who have glaucoma without first consulting child's doctor.
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
While using this product:
• do not exceed recommended dosage • excitability may occur especially in children • drowsiness may occur; alcohol, sedatives and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Use caution when driving a motor vehicle or operating machinery.
Stop use and ask a doctor if:
• you get nervous, dizzy or sleepless • new symptoms occur • symptoms do not get better within 7 days or are accompanied by fever • coughs lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of serious conditions.
If pregnant or breast-feeding, ask a health professional before use.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Compare to Tussi- Pres B®
Brompheniramine Maleate
ANTIHISTAMINE
Dextromethorphan HBr
COUGH SUPPRESSANT
Phenylephrine HCl
NASAL DECONGESTANT
SUGAR AND ALCOHOL FREE
SACCHARINE FREE
DYE FREE
GRAPE FLAVOR
Manufactured in the USA for Kramer Novis. San Juan, Puerto Rico 00917 Tel.787-767-2072 www.kramernovis.com
INGREDIENTS AND APPEARANCE
| PRESGEN B
dextromethorphan hydrobromide, brompheniramine maleate, phenylephrine hydrochloride syrup |
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| Labeler - KRAMER NOVIS (090158395) |
| Registrant - KRAMER NOVIS (090158395) |