Bionel Pediatric
Dosage form: liquid
Ingredients: Dextromethorphan Hydrobromide 5mg in 5mL, Guaifenesin 50mg in 5mL, Pseudoephedrine Hydrochloride 15mg in 5mL
Labeler: Advanced Generic Corporation
NDC Code: 45737-207
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.
Active Ingredients: (in each 5 mL tsp.) Purpose
Guaifenesin 50 mg .............................................. Expectorant
Dextromethorphan Hydrobromide 5 mg.................. Cough Suppressant
Pseudoephedrine HCl 15 mg.................................. Nasal Decongestant
- 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.
- 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.
- 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.
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
- 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.
Questions or comments? 1-305-403-3788
Manufactured For: Advanced Generic Corporation, Miami, Fl 33166
www.advancedgeneric.com
| BIONEL
PEDIATRIC
dextromethorphan, guaifenesin, pseudoephedrine hydrochloride liquid |
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| Labeler - Advanced Generic Corporation (831762971) |
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
