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NDC 45737-0246-16 Biobron 20; 200; 10 mg/5mL; mg/5mL; mg/5mL Details
Biobron 20; 200; 10 mg/5mL; mg/5mL; mg/5mL
Biobron is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Advanced Generic Corporation. 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: 45737-0246-16Last 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: 45737-0246-16Last 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: 45737-0246-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 45737-0246 |
|---|---|
| Product ID | 45737-246_f3635560-0697-432c-b884-a0996647a1fd |
| Associated GPIs | |
| GCN Sequence Number | 066353 |
| GCN Sequence Number Description | guaifen/dextromethorphan/PE LIQUID 200-20-10 ORAL |
| HIC3 | B4R |
| HIC3 Description | NON-OPIOID ANTITUSSIVE-DECONGESTANT-EXPECTORANT |
| GCN | 28597 |
| HICL Sequence Number | 000216 |
| HICL Sequence Number Description | GUAIFENESIN/DEXTROMETHORPHAN HBR/PHENYLEPHRINE |
| Brand/Generic | Generic |
| Proprietary Name | Biobron |
| Proprietary Name Suffix | DX |
| Non-Proprietary Name | Dextromethorphan, Guaifenesin, Phenylephrine |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 20; 200; 10 |
| Active Ingredient Units | mg/5mL; mg/5mL; mg/5mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | Advanced Generic Corporation |
| 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 | 2022-12-31 |
Package
Package Images
NDC 45737-0246-16 (45737024616)
| NDC Package Code | 45737-246-16 |
|---|---|
| Billing NDC | 45737024616 |
| Package | 473 mL in 1 BOTTLE (45737-246-16) |
| Marketing Start Date | 2009-10-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL c2f176e9-b647-43a6-96cd-bad48dd776e9 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Uses
- Temporarily relieves these symptoms, due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies
- Cough due to minor throat and bronchial irritation
- Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive
- Nasal congestion
- Reduces swelling of nasal passages.
SPL UNCLASSIFIED SECTION
Warnings
- Do not exceed recommended dosage
- A
persistent cough may be a sign of a serious condition. If cough
persists for more than a week, tends to reoccur or is accompanied by a
fever, rash or persistent headache, consult a doctor
- If nervousness, dizziness or sleeplessness occur, discontinue use and consult a doctor
- If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.
SPL UNCLASSIFIED SECTION
Do not Use
- For persistent cough such as occurs with smoking, asthma, chronic bronchitis, emphysema or where cough is accompanied by excessive phelgm (mucus), unless directed by a doctor
- If nervousness, dizziness or sleeplessness occur, discontinue use and consult a doctor.
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 you are taking a prescription drug that contains an MAOI;
ask your doctor or pharmacist before taking this product.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| BIOBRON
DX
dextromethorphan, guaifenesin, phenylephrine liquid |
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| Labeler - Advanced Generic Corporation (831762971) |