{"active_ingredient":["Active Ingredients: (in each 5 mL tsp.) Purpose Guaifenesin 50 mg .............................................. Expectorant Dextromethorphan Hydrobromide 5 mg.................. Cough Suppressant Pseudoephedrine HCl 15 mg.................................. Nasal Decongestant"],"do_not_use":["Ask a doctor before use if your child hav e 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."],"dosage_and_administration":["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"],"effective_time":"20241220","id":"29bc44a9-43f2-1d34-e063-6394a90aec4a","inactive_ingredient":["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."],"indications_and_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 14 mg of Phenylalanine per 5 mL (one teaspoonful) dose."],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{},"package_label_principal_display_panel":["BionelPedLabel"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["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."],"questions":["Questions or comments? 1-305-403-3788 Manufactured For: Advanced Generic Corporation, Miami, Fl 33166 www.advancedgeneric.com"],"set_id":"271c5895-25f5-4162-a278-6629b0ad03c1","spl_product_data_elements":["Bionel Pediatric Dextromethorphan, Guaifenesin, Pseudoephedrine Hydrochloride CORN SYRUP WATER POTASSIUM CITRATE POTASSIUM SORBATE PROPYLENE GLYCOL PROPYLPARABEN CITRIC ACID MONOHYDRATE ASPARTAME METHYLPARABEN D&C RED NO. 33 DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE"],"version":"8","warnings":["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."]}