BIO DTUSS DMX- brompheniramine maleate, dextromethorphan, pseudoephedrine liquid

BIO Dtuss by

Drug Labeling and Warnings

BIO Dtuss by is a Otc medication manufactured, distributed, or labeled by Advanced Generic Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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
  

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.
  

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

Stop use and ask a doctor if:

• 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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

DOSAGE & ADMINISTRATION

Directions:

• adults and children 12 years of age and over: take 1 teaspoonfull every 6 hours
• children 6 to under 12 years of age: take 1/2 teaspoonfull every 6 hours
• children under 6 years of age: ask doctor

INDICATIONS & USAGE

Other Information:

store at room temperature 15-30 degrees celcius (59-86 degrees farenheit)

Tamper Evident Feature Do not use if seal under cap(or cello band over cap) is torn, broken or missing

INACTIVE INGREDIENT

Inactive Ingredients:

 Glycerin, Propylene Glycol, Methylparaben, Propylparaben, Sucrose, Citric Acid, Sodium Citrate, D and C Red #33, FD and C Blue #1, Grape Flavor and Purified Water.

QUESTIONS

Question and Comments? 1-305-403-3788

Advanced Generic Corporation, Miami, FL 33166

www.advancedgeneric.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIO DTUSS  DMX
brompheniramine maleate, dextromethorphan, pseudoephedrine liquid

Product 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)