BIONEL PEDIATRIC- dextromethorphan hydrobromide, guaifenesin and pseudoephedrine hydrochloride liquid
Advanced Generic Corporation
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.
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Active Ingredients: (in each 5 mL tsp.) Purpose
Guaifenesin 50 mg .............................................. Expectorant
Dextromethorphan Hydrobromide 5 mg.................. Cough Suppressant
Pseudoephedrine HCl 15 mg.................................. Nasal Decongestant
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
- temporarily relieves these symptoms occurring with a cold: nasal congestion, cough due to minor throat and bronchial irritation.
Warnings
Do not use in a child who is 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.
Ask a doctor before use if your child 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.
If pregnant or breast-feeding, ask a health professional before use.
Directions Do not exceed more than 4 doses in any 24-hour period or as directed by a doctor.
Children 6 to under 12 years of age; 45 lbs to under 95 lbs; Take 2 teaspoonfuls (10mL) every 4 to 6 hours
Children 2 to under 6 years of age; 25 lbs to under 45 lbs; Take 1 teaspoonful (5mL) every 4 to 6 hours
Children under 2 years of age; Under 25 lbs; Ask a doctor
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 14 mg of Phenylalanine per 5 mL (one teaspoonful) dose.
Inactive ingredients aspartame, citric acid, corn syrup, D and C Red No 33, methylparaben, natural and artificial flavors, potassium citrate, potassium sorbate, propylparaben, propylene glycol, purified water.
Questions or comments? 1-305-403-3788
Manufactured For: Advanced Generic Corporation, Miami, Fl 33166
www.advancedgeneric.com