{"active_ingredient":["Active ingredients & Purposes Active Ingredients (in each packet) Purposes Acetaminophen 650 mg Pain reliever/ fever reducer Diphenhydramine HCL 25 mg Antihistamine/ cough suppressant Phenylephrine HCL 10 mg Nasal decongestant"],"active_ingredient_table":["
Active Ingredients (in each packet)
Purposes
Acetaminophen 650 mg
Pain reliever/ fever reducer
Diphenhydramine HCL 25 mg
Antihistamine/ cough suppressant
Phenylephrine HCL 10 mg
Nasal decongestant
"],"ask_doctor":["Ask a doctor before use if you have liver disease have heart disease have high blood pressure have thyroid disease have diabetes have glaucoma have a breathing problem such as emphysema have difficulty urinating due to an enlarged prostate gland have a breathing problem such as emphysema or chronic bronchitis are taking sedatives or tranquilizers"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin"],"do_not_use":["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. with any other product containing diphenhydramine, even one used on skin"],"dosage_and_administration":["Directions dissolve one packet in an 8 fl oz glass of hot water. If using a microwave; add content into a glass of cool water and stir briskly before and after heating. Do not overheat. Sip while hot and consume the entire drink within 10-15 minutes adults and children 12 years of age and older: one (1) packet every 4 hours, do not exceed 6 packets per 24 hours children under 12 years of age: do not use"],"effective_time":"20260115","id":"4873c00c-3edf-844a-e063-6394a90ac80d","inactive_ingredient":["Inactive ingredients acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow #10, eucalyptus honey lemon flavors, FD&C blue #1, FD&C red #40, isopropyl alcohol, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate, water"],"indications_and_usage":["Uses Temporarily relieves common cold/flu symptoms: minor aches and pains sore throat headache nasal congestion runny nose itchy nose and throat cough due to minor throat & bronchial irritation and temporarily reduces fever"],"keep_out_of_reach_of_children":["Kepp out of reach of children. In case of accidental 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."],"openfda":{"application_number":["M012"],"brand_name":["SanaTos Severe Cold Relief Nighttime"],"generic_name":["ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Pharmadel LLC"],"package_ndc":["55758-385-06"],"product_ndc":["55758-385"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1659960"],"spl_id":["4873c00c-3edf-844a-e063-6394a90ac80d"],"spl_set_id":["144aafcc-6ec2-a322-e063-6294a90afc27"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE","PHENYLEPHRINE HYDROCHLORIDE","ACETAMINOPHEN"],"unii":["TC2D6JAD40","04JA59TNSJ","362O9ITL9D"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL SN EHL PDP"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Active Ingredients (in each packet) Purposes Acetaminophen 650 mg Pain reliever/ fever reducer Diphenhydramine HCL 25 mg Antihistamine/ cough suppressant Phenylephrine HCL 10 mg Nasal decongestant"],"purpose_table":["
Active Ingredients (in each packet)
Purposes
Acetaminophen 650 mg
Pain reliever/ fever reducer
Diphenhydramine HCL 25 mg
Antihistamine/ cough suppressant
Phenylephrine HCL 10 mg
Nasal decongestant
"],"questions":["Questions? +1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com"],"set_id":"144aafcc-6ec2-a322-e063-6294a90afc27","spl_product_data_elements":["SanaTos Severe Cold Relief Nighttime Acetaminophen, Diphenhydramine hydrochloride, and Phenylephrine hydrochloride ISOPROPYL ALCOHOL WATER DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ACESULFAME POTASSIUM ASPARTAME ANHYDROUS CITRIC ACID D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C RED NO. 40 MALTODEXTRIN SILICON DIOXIDE SODIUM CITRATE SUCROSE TRIBASIC CALCIUM PHOSPHATE ACETAMINOPHEN ACETAMINOPHEN Eucalyptus Honey Lemon"],"spl_unclassified_section":["Drug Facts Drug Facts","Distributed by: PHARMADEL LC New Castle, DE 19720 Made in India"],"stop_use":["Stop use and ask doctor if nervousness, dizziness, or sleeplessness occur redness or swelling is present pain, cough, or nasal congestion persists or gets worse or last more than 7 days fever gets worse or lasts more than 3 days any new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition."],"storage_and_handling":["Other information each packet contains: potassium 10 mg, sodium 27 mg phenylketonurics: contains phenylalanine 13 mg per packet store at room temperature 68-77°F (20-25°C) do not use if packets are punctured or torn."],"version":"8","warnings":["Warnings Liver warning: This product contains acetaminophen . Severe liver damage may occur if you take more than 6 doses in 24 hours , which is the maximum daily amount with other drugs containing 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 a 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. with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have liver disease have heart disease have high blood pressure have thyroid disease have diabetes have glaucoma have a breathing problem such as emphysema have difficulty urinating due to an enlarged prostate gland have a breathing problem such as emphysema or chronic bronchitis are taking sedatives or tranquilizers Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not exceed recommended dosage may cause excitability, especially in children use caution when driving a motor vehicle or operating machinery may cause marked drowsiness Stop use and ask doctor if nervousness, dizziness, or sleeplessness occur redness or swelling is present pain, cough, or nasal congestion persists or gets worse or last more than 7 days fever gets worse or lasts more than 3 days any 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. Kepp out of reach of children. In case of accidental 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."],"when_using":["When using this product do not exceed recommended dosage may cause excitability, especially in children use caution when driving a motor vehicle or operating machinery may cause marked drowsiness"]}