BIONATUSS DXP- dexbrompheniramine maleate, dextromethorphan, phenylephrine liquid

Bionatuss by

Drug Labeling and Warnings

Bionatuss 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

Dexbrompheniramine Maleate.............2mg................................Antihistamine

Dextromethorphan HBr..................20mg.................................Cough Suppressant

Phenylephrine HCL......................10mg................................. Nasal Descongestant

PURPOSE

Purpose

Antihistamine

Cough Suppressant

Nasal Decongestant

INDICATIONS & USAGE

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

WARNINGS

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.

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: 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

INACTIVE INGREDIENT

Inactive ingredients: artificial flavor, citric acid, glycerin, methylparaben, propylene glycol, propylparaben, water, sodium citrate and sucralose.

QUESTIONS

Questions or comments? 1-305-403-3788

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIONATUSS  DXP
dexbrompheniramine maleate, dextromethorphan, phenylephrine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45737-210
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP)	DEXBROMPHENIRAMINE MALEATE	2 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	RASPBERRY (Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45737-210-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/01/2009

Labeler - Advanced Generic Corporation (831762971)