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NDC 45737-0210-16 Bionatuss 2; 20; 10 mg/5mL; mg/5mL; mg/5mL Details
Bionatuss 2; 20; 10 mg/5mL; mg/5mL; mg/5mL
Bionatuss is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Advanced Generic Corporation. The primary component is DEXBROMPHENIRAMINE 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: 45737-0210-16Last 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: 45737-0210-16Last 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: 45737-0210-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 45737-0210 |
|---|---|
| Product ID | 45737-210_2c36395e-c0a5-42a6-ba75-977b33b65aac |
| Associated GPIs | 43995803500920 |
| GCN Sequence Number | 052995 |
| GCN Sequence Number Description | d-methorphan/pe/dexbromphenir SYRUP 20-10-2/5 ORAL |
| HIC3 | B3R |
| HIC3 Description | NON-OPIOID ANTITUS-1ST GEN.ANTIHISTAMINE-DECONGEST |
| GCN | 20305 |
| HICL Sequence Number | 025559 |
| HICL Sequence Number Description | DEXTROMETHORPHAN HBR/PHENYLEPHRINE HCL/DEXBROMPHENIRAMINE |
| Brand/Generic | Generic |
| Proprietary Name | Bionatuss |
| Proprietary Name Suffix | DXP |
| Non-Proprietary Name | Dexbrompheniramine Maleate, Dextromethorphan, Phenylephrine |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 2; 20; 10 |
| Active Ingredient Units | mg/5mL; mg/5mL; mg/5mL |
| Substance Name | DEXBROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; 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 | 2024-12-31 |
Package
Package Images
NDC 45737-0210-16 (45737021016)
| NDC Package Code | 45737-210-16 |
|---|---|
| Billing NDC | 45737021016 |
| Package | 473 mL in 1 BOTTLE (45737-210-16) |
| Marketing Start Date | 2009-10-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL e57de19a-bf2f-405c-bc84-6ccae6055a46 Details
SPL UNCLASSIFIED SECTION
Active Ingredients (in each 5 mL tsp.) Purpose
Dexbrompheniramine Maleate.............2mg................................Antihistamine
Dextromethorphan HBr..................20mg.................................Cough Suppressant
Phenylephrine HCL......................10mg................................. Nasal Descongestant
SPL UNCLASSIFIED SECTION
Uses
- helps to control the relex that causes coughing
- temporarily relieves nasal congestion due to common cold, hay fever, or other upper respiratory allergies (allergic rhinitis)
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- sneezing
- itching of the nose or throat
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 your prescription contains an MAOI, ask a doctor or pharmacist before using the product.
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a cough with too much phlegm (mucus)
- a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask a docotor before use if you are taking sedatives or tranquilizers
When using this product
- do not exceed recommended dose
- excitability may occur, especially in children
- drowsiness may occur
- avoid alcoholic beverages
- alcohol, sedatives and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating
Stop use and ask a doctor if
- nervousness, dizziness or sleeplessness occurs
- cough lasts for more than 7 days, comes back, or occurs with a fever, rash, or headache that lasts.
- These could be signs of a serious condition.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Directions: Do not exceed more than 6 doses in any 24-hour period or
as directed by a doctor.
| Adults and children 12 years of age and over | take 1 teaspoonful (5 mL) every 4 hours |
| Children 6 to under 12 years of age | take 1/2 teaspoonful (2.5 mL) every 4 hours |
| Children under 6 years of age | ask a doctor |
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| BIONATUSS
DXP
dexbrompheniramine maleate, dextromethorphan, phenylephrine liquid |
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| Labeler - Advanced Generic Corporation (831762971) |