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NDC 45737-0203-16 BIO Dtuss 1; 20; 30 mg/5mL; mg/5mL; mg/5mL Details
BIO Dtuss 1; 20; 30 mg/5mL; mg/5mL; mg/5mL
BIO Dtuss is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Advanced Generic Corporation. The primary component is BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE 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: 45737-0203-16Last 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: 45737-0203-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan
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: 45737-0203-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pseudoephedrine
Product Information
NDC | 45737-0203 |
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Product ID | 45737-203_5ebcff2f-3f3a-436a-8ab1-44928941f2a1 |
Associated GPIs | 43995803320910 |
GCN Sequence Number | 058643 |
GCN Sequence Number Description | brompheniramine/pseudoephed/DM LIQUID 1-30-20/5 ORAL |
HIC3 | B3R |
HIC3 Description | NON-OPIOID ANTITUS-1ST GEN.ANTIHISTAMINE-DECONGEST |
GCN | 24117 |
HICL Sequence Number | 000389 |
HICL Sequence Number Description | BROMPHENIRAMINE MALEATE/PSEUDOEPHEDRINE HCL/DEXTROMETHORPHAN |
Brand/Generic | Generic |
Proprietary Name | BIO Dtuss |
Proprietary Name Suffix | DMX |
Non-Proprietary Name | Brompheniramine Maleate, Dextromethorphan, Pseudoephedrine |
Product Type | HUMAN OTC DRUG |
Dosage Form | LIQUID |
Route | ORAL |
Active Ingredient Strength | 1; 20; 30 |
Active Ingredient Units | mg/5mL; mg/5mL; mg/5mL |
Substance Name | BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; 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 45737-0203-16 (45737020316)
NDC Package Code | 45737-203-16 |
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Billing NDC | 45737020316 |
Package | 473 mL in 1 BOTTLE (45737-203-16) |
Marketing Start Date | 2011-12-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 9eb28921-8917-4c82-9994-853e36c74431 Details
SPL UNCLASSIFIED SECTION
Active Ingredients(in each 5 mL tsp.) Purpose
Brompheniramine Maleate...................... 1mg ..................................Antihistamine
Dextromethorphen HBr........................... 20 mg ............................Cough Suppressant
Pseudoephedrine HCl............................. 30mg .............................Nasal Decongestant
SPL UNCLASSIFIED SECTION
Uses:
- Temporarily relieves cough due to minor throat and bronchial irritation as may occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies or associated with sinusitis
- Temporarily relieves these symptoms due to hay fever(allergies rhinitis)
- Runny nose
- Sneezing
- Itchy, watery eyes
- Itchy of the nose or throat
- Temporarily restores free breathing through the nose
SPL UNCLASSIFIED SECTION
Warnings:
- May cause excitability especially in children. May cause drowsiness, alcohol, sedatives and tranquilizers may increase the drowsiness effect. Avoid alcohol beverages while taking this product. Do not take this product if you have taken sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery.
- Do not exceed recommended dosage. 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:
Ask a doctor before use if you have:
- Cough that occurs with too much phlegm (mucus)
- Heart disease
- High blood pressure
- Thyroid disease
- Diabetes
- Glaucoma
- Trouble urinating due to an enlarged prostate gland
- A breathing problem or persistent or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
- You get nervous, dizzy or sleepless
- Symptoms do not get better within 7 days, comes back, or is accompaniend by fever, rash or persistent headache. These could be signs of a serious condition
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
BIO DTUSS
DMX
brompheniramine maleate, dextromethorphan, pseudoephedrine liquid |
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Labeler - Advanced Generic Corporation (831762971) |
Registrant - Advanced Generic Corporation (831762971) |