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NDC 45737-0225-16 BioTPres 15; 200; 5 mg/5mL; mg/5mL; mg/5mL Details
BioTPres 15; 200; 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.
Product Information
NDC | 45737-0225 |
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Product ID | 45737-225_7ae95891-2078-4569-bbcf-c96fadc2fc6f |
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 | Brand |
Proprietary Name | BioTPres |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Dextromethorphan, Guaifenesin, Phenylephrine |
Product Type | HUMAN OTC DRUG |
Dosage Form | LIQUID |
Route | ORAL |
Active Ingredient Strength | 15; 200; 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 45737-0225-16 (45737022516)
NDC Package Code | 45737-225-16 |
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Billing NDC | 45737022516 |
Package | 473 mL in 1 BOTTLE (45737-225-16) |
Marketing Start Date | 2009-10-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 42eb824f-4de4-4c67-9932-6038a8dbea8c Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
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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 you have
- 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
- 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 serous condition.
SPL UNCLASSIFIED SECTION
Directions Do not exceed 6 doses in 24 hours.
adults and children 12 years of age and over take 2 teaspoonful (10 mL) every 4 hours
children 6 to under 12 years of age take 1 teaspoonful (5 mL) every 4 hours
children 2 to under 6 years of age take 1/2 teaspoonful (2.5 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
dextromethorphan, guaifenesin, phenylephrine liquid |
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Labeler - Advanced Generic Corporation (831762971) |