BIONEL- dextromethorphan, guaifenesin, pseudoephedrine hydrochloride liquid

Bionel by

Drug Labeling and Warnings

Bionel 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

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

Dextromethorphan Hydrobromide 15 mg.................. Cough Suppressant

Pseudoephedrine HCl 30 mg.................................. Nasal Decongestant

PURPOSE

Uses

• temporarily relieves nasal congestion due to the common cold and thin bronchial secretions to make coughs more productive
• temporary relief of cough due to minor throat and bronchial irritation
• helps to control reflex that causes coughing
  

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 you are
taking a prescription drug that contains a MAOI; ask a doctor or
pharmacist before taking this product.

DO NOT USE

Ask a doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• difficulty in urination due to the enlargement of the prostate gland
  
• a cough that occurs with too much phlegm (mucus)
  
• a breathing problem or chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis, or emphysema. A persistent cough may be a sign of a serious condition.

Stop use and ask a doctor if

• you get nervous, dizzy or sleepless
• symptoms do not get better within 7 days or accompanied by fever
  
• cough lasts more than 7 days, comes back or is accompanied 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.

PREGNANCY OR BREAST FEEDING

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

DOSAGE & ADMINISTRATION

Directions Do not exceed 4 doses in 24 hours.

adults and children 12 years of age and over take 2 teaspoonful (10 mL) every 6 hours

children 6 to under 12 years of age take 1 teaspoonful (5 mL) every 4 hours

children under 6 years of age  ask a doctor

INDICATIONS & USAGE

Other information

• store at controlled room temperature 20°- 25°C (68° - 77°F); excursion permitted to 15°- 30°C (59°- 86°F) [See USP Controlled Room Temperature]. Tamper evident by imprinted heat seal under cap. Do not use if there is evidence of tampering.
  

Warning: Phenylketonuric: Contains 19 mg of Phenylalanine per 5 mL (one teaspoonful) dose.

INACTIVE INGREDIENT

Inactive ingredients aspartame, citric acid, glycerine, methylparaben, natural and artificial flavors, potassium citrate, potassium sorbate, propylene glycol, propylparaben, purified water

QUESTIONS

Questions or comments? 1-305-403-3788

Manufactured For: Advanced Generic Corporation, Miami, Fl 33166

www.advancedgeneric.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIONEL 
dextromethorphan, guaifenesin, pseudoephedrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45737-206
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS)	Dextromethorphan Hydrobromide	15 mg  in 5 mL
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	200 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)
Water (UNII: 059QF0KO0R)
potassium citrate (UNII: EE90ONI6FF)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Propylene Glycol (UNII: 6DC9Q167V3)
propylparaben (UNII: Z8IX2SC1OH)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Aspartame (UNII: Z0H242BBR1)
methylparaben (UNII: A2I8C7HI9T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45737-206-16	473 mL in 1 BOTTLE

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)