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NDC 45737-0207-16 Bionel 5; 50; 15 mg/5mL; mg/5mL; mg/5mL Details
Bionel 5; 50; 15 mg/5mL; mg/5mL; mg/5mL
Bionel 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; PSEUDOEPHEDRINE 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: 45737-0207-16Last 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: 45737-0207-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin
Pseudoephedrine is used to relieve nasal congestion caused by colds, allergies, and hay fever. It is also used to temporarily relieve sinus congestion and pressure. Pseudoephedrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Pseudoephedrine is in a class of medications called nasal decongestants. It works by causing narrowing of the blood vessels in the nasal passages.
Related Packages: 45737-0207-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pseudoephedrine
Product Information
| NDC | 45737-0207 |
|---|---|
| Product ID | 45737-207_27ff6a28-8f3a-4a42-9cc9-0fe1afb85799 |
| Associated GPIs | 43997303320915 |
| GCN Sequence Number | 033849 |
| GCN Sequence Number Description | guaifenesin/DM/pseudoephedrine LIQUID 50-5-15/5 ORAL |
| HIC3 | B4R |
| HIC3 Description | NON-OPIOID ANTITUSSIVE-DECONGESTANT-EXPECTORANT |
| GCN | 53357 |
| HICL Sequence Number | 000222 |
| HICL Sequence Number Description | GUAIFENESIN/DEXTROMETHORPHAN HBR/PSEUDOEPHEDRINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Bionel |
| Proprietary Name Suffix | Pediatric |
| Non-Proprietary Name | Dextromethorphan, Guaifenesin, Pseudoephedrine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 5; 50; 15 |
| Active Ingredient Units | mg/5mL; mg/5mL; mg/5mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE |
| Labeler Name | Advanced Generic Corporation |
| Pharmaceutical Class | Adrenergic alpha-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-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 45737-0207-16 (45737020716)
| NDC Package Code | 45737-207-16 |
|---|---|
| Billing NDC | 45737020716 |
| Package | 473 mL in 1 BOTTLE (45737-207-16) |
| Marketing Start Date | 2009-10-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 271c5895-25f5-4162-a278-6629b0ad03c1 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
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 you are
taking a prescription drug that contains a MAOI; ask a doctor or
pharmacist before taking this product.
SPL UNCLASSIFIED SECTION
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- difficulty in urination due to the enlargement of the prostate gland
- a cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis, or emphysema. A persistent cough may be a sign of a serious condition.
- you get nervous, dizzy or sleepless
- symptoms do not get better within 7 days or 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
Directions Do not exceed more than 4 doses in any 24-hour period or as directed by a doctor.
Children 6 to under 12 years of age; 45 lbs to under 95 lbs; Take 2 teaspoonfuls (10mL) every 4 to 6 hours
Children 2 to under 6 years of age; 25 lbs to under 45 lbs; Take 1 teaspoonful (5mL) every 4 to 6 hours
Children under 2 years of age; Under 25 lbs; Ask a doctor
SPL UNCLASSIFIED SECTION
- store at controlled room temperature 20°- 25°C (68° - 77°F); excursion permitted to 15°- 30°C (59°- 86°F) [See USP Controlled Room Temperature]. Tamper evident by imprinted heat seal under cap. Do not use if there is evidence of tampering.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| BIONEL
PEDIATRIC
dextromethorphan, guaifenesin, pseudoephedrine hydrochloride liquid |
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| Labeler - Advanced Generic Corporation (831762971) |