{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-06-02", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo pack Dextromethorphan HBr, Guaifenesin, Acetaminophen, Doxylamine Succinate Cough and Chest Congestion Maximum Strength Dextromethorphan HBr, Guaifenesin GUAIFENESIN GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN BLUEBERRY WATER AGAVE TEQUILANA JUICE Golden Nighttime Severe Cold and Flu acetaminophen, dextromethorphan hydrobromide, doxylamine succinate WATER ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN CHAMOMILE DOXYLAMINE SUCCINATE DOXYLAMINE AGAVE TEQUILANA JUICE BLUEBERRY Light" ], "spl_unclassified_section": [ "Daytime Cough & Chest Congestion ** Drug Facts", "Nighttime Cold & Flu* Drug Facts", "Do not take both products within 6 hours of each other. DO NOT use if seal under the cap is disturbed or missing. SHAKE WELL BEFORE EACH USE *U.S. Patent No. 11,617,795 | **Patent Pending Distributed by: Genexa Inc. Atlanta, GA 30324 | genexa.com", "Made in the USA with globally sourced ingredients NDC 69676-0079-3" ], "active_ingredient": [ "Active ingredients (in each 20 mL) Dextromethorphan HBr 20 mg Guaifenesin 400 mg", "Active ingredients (in each 20 mL) Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine Succinate 12.5 mg" ], "purpose": [ "Purposes Cough suppressant Expectorant", "Purposes Pain reliever/fever reducer Cough suppressant Antihistamine" ], "indications_and_usage": [ "Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing 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" ], "warnings": [ "Warnings Do not use 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 persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) When using this product do not use more than directed Stop use and ask a doctor if 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 (1-800-222-1222).", "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 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 enlarge 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 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." ], "do_not_use": [ "Do not use 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 MAOI, ask a doctor or pharmacist before taking this product." ], "ask_doctor": [ "Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus)", "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 enlarge prostate gland" ], "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" ], "stop_use": [ "Stop use and ask a doctor if 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.", "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." ], "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." ], "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).", "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." ], "dosage_and_administration": [ "Directions SHAKE WELL BEFORE EACH USE do not take more than 6 doses in any 24-hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours children under 12 years of age: do not use", "Directions SHAKE WELL BEFORE EACH USE only take as directed only use the dose cup provided do not exceed 4 doses per 24 hrs 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" ], "storage_and_handling": [ "Other information store between 20-25ºC (68-77ºF) do not refrigerate", "Other information store between 20-25°C (68-77°F) do not refrigerate" ], "inactive_ingredient": [ "Inactive ingredients organic agave syrup, organic blueberry flavor, natural flavors, purified water", "Inactive ingredients organic agave syrup, organic blueberry flavor, organic chamomile extract, natural flavors, purified water" ], "questions": [ "Questions? 1-855-436-3921 You may also report side effects to this phone number.", "Questions? 1-855-436-3921 You may also report side effects to this phone number." ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin" ], "dosage_and_administration_table": [ "
adults & children 12 yrs & over20 mL every 6 hours
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use
" ], "recent_major_changes": [ "Daytime Cough & Chest Congestion Directions SHAKE WELL BEFORE EACH USE do not take more than 6 doses in any 24-hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours children under 12 years of age: do not use Nighttime Cold & Flu Directions SHAKE WELL BEFORE EACH USE only take as directed only use the dose cup provided do not exceed 4 doses per 24 hrs 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" ], "recent_major_changes_table": [ "
adults & children 12 yrs & over20 mL every 6 hours
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use
" ], "package_label_principal_display_panel": [ "Day & Night Combo Pack Genexa® MEDICINE MADE CLEAN Daytime Maximum Strength Cough & Chest Congestion Dextromethorphan HBr - Cough Suppressant Guaifenesin - Expectorant Cough Mucus Chest Congestion 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) 10099-GNX_R-20241024" ], "set_id": "18835205-a9e3-15c2-e063-6394a90a8107", "id": "38f8afad-542e-ae0c-e063-6294a90a243f", "effective_time": "20250702", "version": "2", "openfda": { "application_number": [ "M013" ], "brand_name": [ "Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo pack" ], "generic_name": [ "DEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN, DOXYLAMINE SUCCINATE" ], "manufacturer_name": [ "Genexa Inc." ], "product_ndc": [ "69676-0079" ], "product_type": [ "HUMAN OTC DRUG" ], "rxcui": [ "2692302", "2692303", "2692304" ], "spl_id": [ "38f8afad-542e-ae0c-e063-6294a90a243f" ], "spl_set_id": [ "18835205-a9e3-15c2-e063-6394a90a8107" ], "package_ndc": [ "69676-0079-3", "69676-0077-9", "69676-0094-9" ], "is_original_packager": [ true ] } } ] }