{"active_ingredient":["Active ingredients (in each 5 mL) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Diphenhydramine HCl 12.5 mg"],"ask_doctor":["Ask a doctor before use if you have • liver disease • glaucoma • a breathing problem such as emphysema or chronic bronchitis • trouble urinating due to enlargement of the prostate gland • cough that occurs with too much phlegm (mucus) • a chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin, tranquilizers or sedatives."],"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 the skin"],"dosage_and_administration":["Directions • take every 4 to 6 hours • do not exceed more than 5 doses in 24 hours for children under 12 years of age • do not exceed more than 6 doses in 24 hours for adults and children over 12 years of age adults & children 12 years & over 10 mL (2 teaspoonfuls) children 6 years to under 12 years 5 mL (1 teaspoonful) children under 6 years ask a doctor"],"dosage_and_administration_table":["<table width=\"100%\"> <col width=\"50%\"/> <col width=\"50%\"/> <tbody> <tr> <td styleCode=\"Rrule Botrule Toprule \" valign=\"top\"> <paragraph>adults &amp; children 12 years &amp; over</paragraph> </td> <td styleCode=\"Botrule Lrule Toprule \" valign=\"top\"> <paragraph>10 mL (2 teaspoonfuls)</paragraph> </td> </tr> <tr> <td styleCode=\"Rrule Botrule \" valign=\"top\"> <paragraph>children 6 years to under 12 years</paragraph> </td> <td styleCode=\"Lrule Botrule \" valign=\"top\"> <paragraph>5 mL (1 teaspoonful)</paragraph> </td> </tr> <tr> <td styleCode=\"Rrule Botrule \" valign=\"top\"> <paragraph>children under 6 years</paragraph> </td> <td styleCode=\"Botrule \" valign=\"top\"> <paragraph>ask a doctor</paragraph> </td> </tr> </tbody> </table>"],"effective_time":"20191217","id":"2754aad5-00ec-4788-9efd-2d0c774804d8","inactive_ingredient":["Inactive ingredients Acesulfame potassium, aspartame, citric acid, hypromellose, menthol, methylparaben, natural & artificial orange flavor, polyethylene glycol, potassium sorbate, propylene glycol, purified water. Sodium citrate may be used to adjust pH."],"indications_and_usage":["Uses temporarily relieves common cold/flu symptoms including: • cough due to minor throat and bronchial irritation • sore throat • headache • minor aches and pains • muscular aches • fever • runny nose and sneezing"],"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. Prompt medical attention is critical even if you do not notice any signs or symptoms."],"openfda":{},"package_label_principal_display_panel":["Package/Label Principal Display Panel NDC 61787-452-04 Diabetic Tussin ® DECONGESTANT FREE Nighttime Cold & Flu FEVER, HEADACHE BODY ACHES COUGHS SNEEZING RUNNY NOSE Liquid NO Sodium Sorbitol Fructose & Dyes ACETAMINOPHEN DEXTROMETHORPHAN HBr DIPHENHYDRAMINE HCl SAFE FOR DIABETICS SUGAR & ALCOHOL FREE! GLUTEN FREE 4 FL OZ (118 mL) Image of Carton - 118 mL"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purposes Pain Relief Cough Suppressant Antihistamine"],"questions":["Questions or comments? Call: 1-800-899-3116 , Mon-Thurs 9:00 am - 5:00 pm EST, Fri 9:00 am - 2:30 pm EST. Serious side effects associated with use of this product may be reported to this number. Rev. 452:04 12/11"],"set_id":"96ef6c88-ce06-4d7a-ab7b-42af64ba3149","spl_product_data_elements":["Diabetic Tussin Nighttime Cold and Flu Acetaminophen, Dextromethorphan HBr, and Diphenhydramine HCl WATER ASPARTAME ACESULFAME POTASSIUM HYPROMELLOSE 2910 (4000 MPA.S) POLYETHYLENE GLYCOL 400 POTASSIUM SORBATE ANHYDROUS CITRIC ACID PROPYLENE GLYCOL METHYLPARABEN MENTHOL, UNSPECIFIED FORM TRISODIUM CITRATE DIHYDRATE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE clear, colorless to light brown natural & artificial orange flavor"],"spl_unclassified_section":["Other information • Phenylketonurics : contains phenylalanine 8.4 mg per teaspoonful (5 mL) • Store at room temperature 20-25°C (68-77°F)"],"stop_use":["Stop use and ask a doctor if • redness or swelling is present • fever gets worse or lasts more than 3 days • new symptoms occur • cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts These could be signs of a serious condition."],"version":"3","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if • adults take more than 6 doses in 24 hours, which is the maximum daily amount • child takes more than 5 doses in 24 hours, which is the maximum daily amount • taken with other drugs containing acetaminophen • adult has 3 or more alcoholic drinks everyday while using this product Sore throat warning: If sore throat is severe, persists for more than two 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 the skin Ask a doctor before use if you have • liver disease • glaucoma • a breathing problem such as emphysema or chronic bronchitis • trouble urinating due to enlargement of the prostate gland • cough that occurs with too much phlegm (mucus) • a chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin, tranquilizers or sedatives. When using this product: • you may get very drowsy • avoid alcoholic drinks • alcohol, sedatives and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in small children Stop use and ask a doctor if • redness or swelling is present • fever gets worse or lasts more than 3 days • new symptoms occur • cough lasts more than 7 days, comes back, or occurs with fever, 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. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical even if you do not notice any signs or symptoms."],"when_using":["When using this product: • you may get very drowsy • avoid alcoholic drinks • alcohol, sedatives and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in small children"]}