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NDC 45737-0227-16 BioTPres 5; 75; 2.5 mg/5mL; mg/5mL; mg/5mL Details
BioTPres 5; 75; 2.5 mg/5mL; mg/5mL; mg/5mL
BioTPres 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: 45737-0227-16Last 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: 45737-0227-16Last 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: 45737-0227-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 45737-0227 |
|---|---|
| Product ID | 45737-227_b5c27388-e0e3-4924-bb72-2386229f78b5 |
| Associated GPIs | 43997303100907 |
| GCN Sequence Number | 058870 |
| GCN Sequence Number Description | guaifen/dextromethorphan/PE LIQUID 75-5-2.5/5 ORAL |
| HIC3 | B4R |
| HIC3 Description | NON-OPIOID ANTITUSSIVE-DECONGESTANT-EXPECTORANT |
| GCN | 24395 |
| HICL Sequence Number | 000216 |
| HICL Sequence Number Description | GUAIFENESIN/DEXTROMETHORPHAN HBR/PHENYLEPHRINE |
| Brand/Generic | Generic |
| Proprietary Name | BioTPres |
| Proprietary Name Suffix | Pediatric |
| Non-Proprietary Name | Dextromethorphan, Guaifenesin, Phenylephrine |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 5; 75; 2.5 |
| 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 45737-0227-16 (45737022716)
| NDC Package Code | 45737-227-16 |
|---|---|
| Billing NDC | 45737022716 |
| Package | 473 mL in 1 BOTTLE (45737-227-16) |
| Marketing Start Date | 2009-10-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL d6b2d191-e2fb-4da4-92e0-35b81e07e673 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
- Temporarily relieves cough due to minor throat and bronchial irritation as may occur with common cold
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus
- temporarily relieves nasal congestion due to the common cold and cough due to minor throat and bronchial irritation.
SPL UNCLASSIFIED SECTION
Warnings
Do not use 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
Do not Use
- In a child under 2 years of age.
Ask a doctor before use if child has
- 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)
- cough that lasts or is chronic as occurs with smoking, asthma, chronic bronchitis or emphysema
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 serous condition.
SPL UNCLASSIFIED SECTION
Directions Do not exceed 6 doses in 24 hours.
adults and children 12 years of age and over take 4 teaspoonful (20 mL) every 4 hours
children 6 to under 12 years of age take 2 teaspoonful (10 mL) every 4 hours
children 2 to under 6 years of age take 1 teaspoonful (5 mL) every 4 hours
children under 2 years of age ask doctor
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| BIOTPRES
PEDIATRIC
dextromethorphan, guaifenesin, phenylephrine liquid |
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| Labeler - Advanced Generic Corporation (831762971) |