Label: BIO DTUSS DMX- brompheniramine maleate, dextromethorphan, pseudoephedrine liquid
- NDC Code(s): 45737-203-16
- Packager: Advanced Generic Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 23, 2020
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ACTIVE INGREDIENT
Active Ingredients(in each 5 mL tsp.) Purpose
Brompheniramine Maleate...................... 1mg ..................................Antihistamine
Dextromethorphen HBr........................... 20 mg ............................Cough Suppressant
Pseudoephedrine HCl............................. 30mg .............................Nasal Decongestant -
PURPOSE
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
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WARNINGS
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.
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DO NOT USE
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
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BIO DTUSS DMX
brompheniramine maleate, dextromethorphan, pseudoephedrine liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45737-203 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE 1 mg in 5 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 5 mL PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg in 5 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) SUCROSE (UNII: C151H8M554) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM CITRATE (UNII: 1Q73Q2JULR) WATER (UNII: 059QF0KO0R) Product Characteristics Color Score Shape Size Flavor GRAPE (Grape Flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45737-203-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/01/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 12/01/2011 Labeler - Advanced Generic Corporation (831762971) Registrant - Advanced Generic Corporation (831762971)