{"active_ingredient":["Drug Facts Active ingredients (in each 5 mL) Guaifenesin, USP 100 mg Phenylephrine HCl, USP 2.5 mg"],"ask_doctor":["Ask a doctor before use if the child has ▪ heart disease ▪ high blood pressure ▪ thyroid disease ▪ diabetes ▪ cough that occurs with too much phlegm (mucus) ▪ persistent or chronic cough such as occurs with asthma"],"dosage_and_administration":["Directions ▪ do not give more than 6 doses in any 24 hour period ▪ measure only with dosing cup provided ▪ do not use dosing cup with other products ▪ dose as follows or as directed by a doctor Age Dose Children 6 years to under 12 years 10 mL every 4 hours Children 4 years to under 6 years 5 mL every 4 hours Children under 4 years do not use"],"dosage_and_administration_table":["
Age
Dose
Children 6 years to under 12 years
10 mL every 4 hours
Children 4 years to under 6 years
5 mL every 4 hours
Children under 4 years
do not use
"],"effective_time":"20260909","id":"b2f9f84b-eb3a-468b-b6b2-7341e243cd0e","inactive_ingredient":["Inactive ingredients anhydrous citric acid, edetate disodium, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose, xanthan gum."],"indications_and_usage":["Uses ▪ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive ▪ temporarily relieves: ▪ nasal congestion due to a cold ▪ stuffy nose"],"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 1-800-222-1222."],"openfda":{"application_number":["M012"],"brand_name":["DRx Choice Childrens Stuffy Nose and Chest Congestion"],"generic_name":["GUAIFENESIN AND PHENYLEPHRINE HCL"],"is_original_packager":[true],"manufacturer_name":["RARITAN PHARMACEUTICALS"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["68163-748-04"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["68163-748"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1485599"],"spl_id":["b2f9f84b-eb3a-468b-b6b2-7341e243cd0e"],"spl_set_id":["7a3bb739-ff50-4d29-b270-d6b084906493"],"substance_name":["GUAIFENESIN","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["495W7451VQ","04JA59TNSJ"]},"package_label_principal_display_panel":["Package Label-Principal Display Panel 4 FL OZ (118 mL Bottle) *Compare to the active ingredients in Children’s Mucinex® Stuffy Nose & Chest Congestion NDC 68163-748-04 DRx Choice® Children's Stuffy Nose & Chest Congestion Guaifenesin ( Expectorant) Phenylephrine HCl ( Nasal Decongestant) Relieves: Stuffy Nose, Chest congestion, Breaks Up Mucus Dosage Cup Included Mixed Berry Flavor Naturally & artificially flavored For Ages 4 & Over 4 FL OZ (118 mL) TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING IMPORTANT: Keep this carton for future reference on full labeling. Manufactured by: Raritan Pharmaceuticals 8 Joanna Court. East Brunswick NJ 08816 DRx Choice Children's Stuffy Nose and chest Congestion"],"package_label_principal_display_panel_table":["
TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING
","
IMPORTANT: Keep this carton for future reference on full labeling.
"],"purpose":["Purposes Expectorant Nasal Decongestant"],"questions":["Questions or Comments? 1-866-467-2748"],"set_id":"7a3bb739-ff50-4d29-b270-d6b084906493","spl_product_data_elements":["DRx Choice Childrens Stuffy Nose and Chest Congestion Guaifenesin and Phenylephrine Hcl GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID EDETATE DISODIUM GLYCERIN PROPYLENE GLYCOL WATER SODIUM BENZOATE TRISODIUM CITRATE DIHYDRATE SORBITOL SUCRALOSE XANTHAN GUM"],"stop_use":["Stop use and ask a doctor if ▪ nervousness, dizziness or sleeplessness occur ▪ symptoms do not get better within 7 days or occur with fever ▪ cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness."],"storage_and_handling":["Other information ▪ each 5 mL contains : sodium 3 mg ▪ very low sodium ▪ store at room temperature ▪ do not refrigerate ▪ dosing cup provided"],"version":"4","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 your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product."],"when_using":["When using this product do not use more than directed"]}