{"active_ingredient":["Active ingredients (in each 20 mL) Acetaminophen 650 mg Dextromethorphan HBr 20 mg","Active ingredients (in each 20 mL) Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine Succinate 12.5 mg"],"ask_doctor":["Ask a doctor before use if you have liver disease cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, or emphysema","Ask a doctor before use if you have liver disease cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema glaucoma trouble urinating due to enlarged prostate gland"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin","Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers 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.","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."],"dosage_and_administration":["Directions SHAKE WELL before each use take only as directed only use the dose cup provided do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 20 mL every 4 hours children 4 to under 12 yrs ask a doctor children under 4 yrs do not use","Directions SHAKE WELL before each use take only as directed only use the dose cup provided do not exceed 4 doses per 24 hours adults & children 12 yrs & over 20 mL every 6 hours children 4 to under 12 yrs ask a doctor children under 4 yrs do not use"],"dosage_and_administration_table":["
adults & children 12 yrs & over20 mL every 4 hours
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use
","
adults & children 12 yrs & over20 mL every 6 hours
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use
"],"effective_time":"20251230","id":"472de7bd-c0e2-bafe-e063-6394a90a5092","inactive_ingredient":["Inactive ingredients organic agave syrup, organic blueberry flavor, natural flavors, purified water, xylitol","Inactive ingredients organic agave syrup, organic blueberry flavor, organic chamomile extract, natural flavors, purified water"],"indications_and_usage":["Uses temporarily reduces fever and relieves these common cold/flu symptoms: minor aches and pains headache sore throat cough due to minor throat and bronchial irritation controls the impulse to cough to help you get to sleep","Uses temporarily relieves these common cold and flu symptoms: cough due to minor throat and bronchial irritation minor aches and pains sore throat headache runny nose sneezing temporarily reduces fever controls cough to help you get to sleep"],"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 (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.","Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away (1-800-222-1222). 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":["M013"],"brand_name":["Daytime and Nighttime Severe Cold and Flu combo pack"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE"],"is_original_packager":[true],"manufacturer_name":["Genexa Inc."],"package_ndc":["69676-0095-3","69676-0093-9","69676-0094-9"],"product_ndc":["69676-0095"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["2692302","2693772","2693777"],"spl_id":["472de7bd-c0e2-bafe-e063-6394a90a5092"],"spl_set_id":["190c7eaf-dcd4-d314-e063-6294a90a6f33"],"upc":["0850015736643"]},"package_label_principal_display_panel":["Day & Night Combo Pack Genexa® MEDICINE MADE CLEAN Daytime Maximum Strength Severe Cold & Flu Acetaminophen - Pain Reliever/Fever Reducer Dextromethorphan HBr - Cough Suppressant Fever Headache Body Aches & Pains Sore Throat Cough Nighttime Severe • Maximum Strength Nighttime Cold & Flu Acetaminophen - Pain Reliever/Fever Reducer Dextromethorphan HBr - Cough Suppressant Doxylamine Succinate - Antihistamine Fever Headache Sore Throat Body Aches & Pains Cough Sneezing Runny Nose Medicine made clean Same effective active ingredients, but no artificial fillers. TWO - 6 FL OZ (177 mL) BOTTLES TOTAL - 12 FL OZ (355 mL) Organic Blueberry Flavor 10052-GNX_R-20240315"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use.","If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purposes Pain reliever/fever reducer Cough suppressant","Purposes Pain reliever/fever reducer Cough suppressant Antihistamine"],"questions":["Questions? 1-855-436-3921 You may also report side effects to this phone number.","Questions? 1-855-426-3921 You may also report side effects to this phone number."],"set_id":"190c7eaf-dcd4-d314-e063-6294a90a6f33","spl_product_data_elements":["Daytime and Nighttime Severe Cold and Flu combo pack Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate Daytime Severe Cold and Flu Acetaminophen, Dextromethorphan HBr AGAVE TEQUILANA JUICE WATER ACETAMINOPHEN ACETAMINOPHEN XYLITOL DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN BLUEBERRY Light Nighttime Severe Cold and Flu acetaminophen, dextromethorphan hydrobromide, doxylamine succinate AGAVE TEQUILANA JUICE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN WATER ACETAMINOPHEN ACETAMINOPHEN BLUEBERRY DOXYLAMINE SUCCINATE DOXYLAMINE CHAMOMILE Light"],"spl_unclassified_section":["Daytime Severe Cold & Flu Drug Facts","Nighttime Severe Cold & Flu Drug Facts","Tamper evident: Do not use if seal under the cap is disturbed or missing. SHAKE WELL before each use. U.S. Patent No. 11,617,795 | Distributed by: Genexa Inc. Atlanta, GA 30324 | genexa.com","Made in the USA with globally sourced ingredients NDC 69676-0095-3"],"stop_use":["Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts 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.","Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts 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."],"storage_and_handling":["Other information store between 20-25°C (68-77°F) do not refrigerate","Other information store between 20-25°C (68-77°F) do not refrigerate"],"version":"2","warnings":["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 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. Ask a doctor before use if you have liver disease cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, 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 pain or cough gets worse or lasts more than 7 days fever gets worse or lasts 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. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.","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 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. Ask a doctor before use if you have liver disease cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema glaucoma trouble urinating due to enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin When using this product do not use more than directed ​ excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts 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. In case of overdose, get medical help or contact Poison Control Center right away (1-800-222-1222). 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 use more than directed.","When using this product do not use more than directed ​ excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness"]}