Package 53041-616-58
Brand: tussnex fm cold and sinus
Generic: acteaminophen, guaifenesin, phenylephrine hclPackage Facts
Identity
Package NDC
53041-616-58
Digits Only
5304161658
Product NDC
53041-616
Description
177 mL in 1 BOTTLE (53041-616-58)
Marketing
Marketing Status
Brand
tussnex fm cold and sinus
Generic
acteaminophen, guaifenesin, phenylephrine hcl
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "3e372558-1578-4c25-962a-43af6b54de75", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["362O9ITL9D", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1116568"], "spl_set_id": ["04c6bb6a-d2f8-4322-afba-e240e8090176"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Guardian Drug Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE (53041-616-58)", "package_ndc": "53041-616-58", "marketing_start_date": "20121201"}], "brand_name": "Tussnex FM Cold and Sinus", "product_id": "53041-616_3e372558-1578-4c25-962a-43af6b54de75", "dosage_form": "LIQUID", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "53041-616", "generic_name": "Acteaminophen, Guaifenesin, Phenylephrine HCl", "labeler_name": "Guardian Drug Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Tussnex FM Cold and Sinus", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/20mL"}, {"name": "GUAIFENESIN", "strength": "400 mg/20mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/20mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20121201", "listing_expiration_date": "20261231"}