{"active_ingredient":["Drug Facts Active Ingredient (in each tablet) Guaifenesin 388 mg Phenylephrine HCl 10 mg"],"ask_doctor":["Ask a doctor before use if you have heart disease excessive phlegm (mucus) high blood pressure diabetes thyroid disease difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema"],"do_not_use":["Do not use more than the recommended dosage this product if you are now 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 are uncertain whether your prescription drug contains an MAOI, ask a health professional."],"dosage_and_administration":["Directions Do not exceed recommended doses in a 24 hour period Adults and Children 12 years and over: 1 tablet every 4 hours. Do not exceed 6 tablets in 24 hours. Children 6 to 12 years: 1/2 tablet every 4 hours. Do not exceed 3 tablets in 24 hours Children under 6 years of age: ask a doctor"],"effective_time":"20260723","id":"5746ab21-fd63-7ac4-e063-6394a90aa199","inactive_ingredient":["Inactive ingredients Croscarmellose Sodium, Hypromellose, Lactose, Magnesium Silicate, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Mineral Oil, Polyethylene Glycol, Polyvinylpyrrolidone, Silica, Sodium Lauryl Sulfate, Stearic Acid, Titanium Dioxide and Triacetin."],"indications_and_usage":["Uses temporarily relieves the symptoms associated with a cough, the common cold, hay fever, or other upper respiratory allergies helps loosen phlegm (mucus) loosens nasal congestion thin bronchial secretions drain bronchial tubes make coughs more productive clears stuffy nose clear nasal passageways shrinks swollen membranes"],"keep_out_of_reach_of_children":["Keep out of the reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center immediately."],"openfda":{"application_number":["M012"],"brand_name":["Giltuss Sinus and Chest Congestion"],"generic_name":["GUAIFENESIN, PHENYLEPHRINE HCL"],"is_original_packager":[true],"manufacturer_name":["Gil Pharmaceutical Corp"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["58552-332-20"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["58552-332"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1946782"],"spl_id":["5746ab21-fd63-7ac4-e063-6394a90aa199"],"spl_set_id":["8591003c-c2f2-df65-e053-2a91aa0a42fb"],"substance_name":["GUAIFENESIN","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["495W7451VQ","04JA59TNSJ"]},"other_safety_information":["Other information Other information store at room temperature, USP do not use if blister seal is broken"],"package_label_principal_display_panel":["MAXIMUM STRENGTH GILTUSS® SINUS & CHEST CONGESTION 20 TABLETS NON-DROWSY. DYE FREE. PRESERVATIVE . SODIUM FREE RELIEVES STUFFY NOSE NASAL CONGESTION SINUS PRESSURE CHEST CONGESTION LOOSENS PHLEGM AND MUCUS 58552-332 Sinus Chest Congestion 11-2-2018"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Expectorant Nasal Decongestant"],"questions":["Questions? Call 787-848-9114"],"set_id":"8591003c-c2f2-df65-e053-2a91aa0a42fb","spl_product_data_elements":["Giltuss Sinus and Chest Congestion Guaifenesin, Phenylephrine HCl GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE STEARIC ACID TITANIUM DIOXIDE TRIACETIN POLYETHYLENE GLYCOL 400 CROSCARMELLOSE SODIUM HYPROMELLOSE, UNSPECIFIED LACTOSE MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE LIGHT MINERAL OIL POVIDONE K30 SILICON DIOXIDE SODIUM LAURYL SULFATE TALC GILGIL;304304"],"spl_unclassified_section":["MANUFACTURED FOR GIL PHARMACEUTICAL CORP. PONCE, PUERTO RICO 00717-1565 giltuss.com"],"stop_use":["Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs symptoms are accompanied by fever, rash, persistent headache, or excessive phlegm (mucus) cough and congestion do not improve within 7 days or tend to recur. These could be signs of a serious condition."],"version":"9","warnings":["Warnings Do not use more than the recommended dosage this product if you are now 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 are uncertain whether your prescription drug contains an MAOI, ask a health professional. Ask a doctor before use if you have heart disease excessive phlegm (mucus) high blood pressure diabetes thyroid disease difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs symptoms are accompanied by fever, rash, persistent headache, or excessive phlegm (mucus) cough and congestion do not improve within 7 days or tend to recur. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center immediately."]}