BIOBRON DX- dextromethorphan, guaifenesin, phenylephrine liquid

Biobron by

Drug Labeling and Warnings

Biobron 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

Dextromethorphan Hydrobromide 20 mg.................. Cough Suppressant

Guaifenesin 200 mg .............................................. Expectorant

Phenylephrine HCl 10 mg.................................. Nasal Decongestant

PURPOSE

Uses

• Temporarily relieves these symptoms, due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies
• Cough due to minor throat and bronchial irritation
• Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive
• Nasal congestion
• Reduces swelling of nasal passages.
  

WARNINGS

Warnings

• Do not exceed recommended dosage
  
• A persistent cough may be a sign of a serious condition. If cough persists for more than a week, tends to reoccur or is accompanied by a fever, rash or persistent headache, consult a doctor
  
• If nervousness, dizziness or sleeplessness occur, discontinue use and consult a doctor
• If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.

DO NOT USE

Do not Use

• For persistent cough such as occurs with smoking, asthma, chronic bronchitis, emphysema or where cough is accompanied by excessive phelgm (mucus), unless directed by a doctor  
• If nervousness, dizziness or sleeplessness occur, discontinue use and consult a doctor.

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.

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 6 doses in 24 hours.

• 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

INDICATIONS & USAGE

Other information  store at room temperature 15 - 30 degrees celcius (59 - 86 degrees farhenheits).

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

QUESTIONS

Questions or comments? 1-305-403-3788
Manufactured For: Advanced Generic Corporation, Miami, FL 33166.
www.advancedgeneric.com

INACTIVE INGREDIENT

Inactive ingredients glycerin, propylene glycol, methylparaben, propylparaben, citric acid, sodium citrate, saccharin calcium,
cherry flavor, purified water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIOBRON  DX
dextromethorphan, guaifenesin, phenylephrine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45737-246
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS)	Dextromethorphan Hydrobromide	20 mg  in 5 mL
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	200 mg  in 5 mL
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	10 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SACCHARIN CALCIUM (UNII: 5101OP7P2I)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45737-246-16	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)