{"active_ingredient":["Acetaminophen 325mg Dextromethorphan HBr 10mg Guaifenesin 200mg Phenylephrine HCl 5mg"],"dosage_and_administration":["Take only as directed (See overdose warning) Do not exceed 4 doses per 24-hours Adults and children 12 years and over: take 2 softgels with water every 4 hours Children 4 to under 12 years: ask a doctor When using other Nighttime or Daytime products, carefully read each label to ensure correct dosing"],"effective_time":"20240517","id":"18adbc15-b127-cc7e-e063-6394a90a1e9c","inactive_ingredient":["FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide"],"indications_and_usage":["Temporarily relieves common cold/flu symptoms: Nasal congestion Sinus congestion & pressure Cough due to minor throat & bronchial irritation Minor aches & pain Headache Fever Sore throat Reduces swelling of nasal passages Temporarily restore freer breathing through the nose Promotes nasal and/or sinus drainage Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{"application_number":["M012"],"brand_name":["Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl"],"generic_name":["ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL"],"is_original_packager":[true],"manufacturer_name":["OPMX LLC"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["69729-782-10"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["69729-782"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1656815"],"spl_id":["18adbc15-b127-cc7e-e063-6394a90a1e9c"],"spl_set_id":["9a164cfc-b623-9a9f-e053-2a95a90a0173"],"substance_name":["ACETAMINOPHEN","GUAIFENESIN","DEXTROMETHORPHAN HYDROBROMIDE","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["362O9ITL9D","495W7451VQ","9D2RTI9KYH","04JA59TNSJ"]},"other_safety_information":["store at room temperature between 20-25°C (68-77ºF) avoid excessive heat and humidity"],"overdosage":["OVERDOSE WARNING: Read directions carefully. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"package_label_principal_display_panel":["COLDTAC"],"purpose":["Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant"],"set_id":"9a164cfc-b623-9a9f-e053-2a95a90a0173","spl_product_data_elements":["Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl POLYETHYLENE GLYCOL 400 GLYCERIN WATER FD&C YELLOW NO. 6 FOOD YELLOW 3 FREE ACID PROPYLENE GLYCOL SORBITOL POVIDONE K30 GELATIN SORBITAN ACETAMINOPHEN ACETAMINOPHEN GUAIFENESIN GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE LIGHT ORANGE 782 Oblong"],"version":"4","warnings":["Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses in 24 hours, which is the maximum daily amount for this product with other drugs contains acetaminophen 3 or more alcoholic drinks every day while using this product. Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult doctor promptly Do not use: with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist 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 do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have: Liver disease High blood pressure Thyroid disease Diabetes Trouble urinating due to enlarged prostate gland Cough that occurs with too much phlegm (mucus) Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product, do not use more than directed. Stop use and ask a doctor if: You get nervous, dizzy, or sleepless Pain, nasal congestion, or cough gets worse or lasts more than 7 days Fever gets worse or last more than 3 days Redness or swelling is present New symptoms occur Cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition. If pregnant or breast-feeding: ask a health professional before use. Keep out of reach of children."]}