{ "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": "2026-06-10", "results": { "skip": 0, "limit": 1, "total": 12 } }, "results": [ { "spl_product_data_elements": [ "Daytime and Nighttime Kids Multi-Symptom Cold and Flu combo pack Acetaminophen, Dextromethorphan HBr, Diphenhydramine HCl Kids Multi Symptom Cold and Flu Acetaminophen, Dextromethorphan HBr DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ACETAMINOPHEN ACETAMINOPHEN AGAVE TEQUILANA JUICE BLUEBERRY WATER Light Kids Nighttime Multi Symptom Cold and Flu Acetaminophen, Diphenhydramine HCl DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE BLUEBERRY WATER AGAVE TEQUILANA JUICE ACETAMINOPHEN ACETAMINOPHEN Light" ], "spl_unclassified_section": [ "Kids' Nighttime Multi-Symptom Cold & Flu Drug Facts", "SHAKE WELL BEFORE EACH USE Do not use if perforated band around the bottle is disturbed or missing.", "Kids' Daytime Multi-Symptom Cold & Flu Drug Facts", "Distributed by: Genexa Inc., Atlanta, GA 30324 genexa.com PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org", "Made in the USA with globally sourced ingredients NDC 69676-0092-3" ], "active_ingredient": [ "Active ingredients (in each 10 mL) Acetaminophen 325 mg Diphenhydramine HCl 12.5 mg", "Active ingredients (in each 10 mL) Acetaminophen 320 mg Dextromethorphan HBr, USP 5 mg" ], "purpose": [ "Purposes Pain reliever/fever reducer Antihistamine/Cough Suppressant", "Purposes Pain reliever/fever reducer Cough Suppressant" ], "indications_and_usage": [ "Uses temporarily reduces fever and relieves these common cold/flu symptoms: minor aches and pains headache cough due to minor throat and bronchial irritation sore throat runny nose sneezing controls the impulse to cough to help your child get to sleep", "Uses temporarily reduces fever and relieves these common cold/flu symptoms: minor aches & pains headache cough due to minor throat and bronchial irritation sore throat controls the impulse to cough to help your child get to sleep" ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes more than 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 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. with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if the child has liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem such as chronic bronchitis persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus). Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product do not use more than directed marked drowsiness may occur sedatives and tranquilizers may increase the drowsiness effect excitability may occur, especially in children Stop use and ask a doctor if pain or cough gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition. Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical even if you do not notice any signs or symptoms.", "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes more than 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 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. in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if the child has liver disease cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus). Ask a doctor or pharmacist before use if the child is 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 5 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. 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 even if you do not notice any signs or symptoms." ], "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. with any other product containing diphenhydramine, even one used on skin", "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. in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product." ], "ask_doctor": [ "Ask a doctor before use if the child has liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem such as chronic bronchitis persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus).", "Ask a doctor before use if the child has liver disease cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus)." ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin taking sedatives or tranquilizers", "Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin" ], "when_using": [ "When using this product do not use more than directed marked drowsiness may occur sedatives and tranquilizers may increase the drowsiness effect excitability may occur, especially in children", "When using this product do not use more than directed" ], "stop_use": [ "Stop use and ask a doctor if pain or cough gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present 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 5 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children.", "Keep out of reach of children." ], "overdosage": [ "Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical even if you do not notice any signs or symptoms.", "In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical even if you do not notice any signs or symptoms." ], "dosage_and_administration": [ "Directions this product does not contain directions or complete warnings for adult use do not give more than directed (see Overdose warning) SHAKE WELL BEFORE EACH USE for accurate dosing, use measuring cup provided. Do not use with any other dosing device. children 6 to under 12 years of age: 10 mL in dosing cup provided every 4 hours while symptoms last, do not give more than 5 times in 24 hours children under 6 years of age: do not use unless directed by a doctor", "Directions this product does not contain directions or complete warnings for adult use do not give more than directed (see Overdose warning) SHAKE WELL BEFORE EACH USE find right dose on chart below for accurate dosing, use measuring cup provided. Do not use with any other dosing device. give dose every 4 hours while symptoms last do not give more than 5 times in 24 hours children 6 to under 12 years 10 mL every 4 hours children 4 to under 6 years 7.5 mL every 4 hours children under 4 years do not use" ], "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" ], "inactive_ingredient": [ "Inactive ingredients agave syrup (organic), blueberry flavor (organic), flavors (natural), purified water", "Inactive ingredients agave syrup (organic), blueberry flavor (organic), flavors (natural), purified water" ], "questions": [ "Questions? 1-855-436-3921", "Questions? 1-855-436-3921" ], "dosage_and_administration_table": [ "
children 6 to under 12 years10 mL every 4 hours
children 4 to under 6 years7.5 mL every 4 hours
children under 4 yearsdo not use
" ], "recent_major_changes": [ "Kids' Nighttime Multi-Symptom Cold & Flu Uses temporarily reduces fever and relieves these common cold/flu symptoms: minor aches and pains headache cough due to minor throat and bronchial irritation sore throat runny nose sneezing controls the impulse to cough to help your child get to sleep" ], "package_label_principal_display_panel": [ "COMBO PACK Genexa ® CLEAN MEDICINE Kids' Multi-Symptom DAYTIME Cold & Flu Ages 4+ ACETAMINOPHEN Pain Reliever/Fever Reducer Dextromethorphan HBr Cough Suppressant Fever, Headache, Sore Throat, Cough, Body Aches & Pains Kids' Multi-Symptom NIGHTTIME Cold & Flu Ages 6+ ACETAMINOPHEN Pain Reliever/Fever Reducer Diphenhydramine HCl Antihistamine/Cough Suppressant Fever, Sore Throat, Body Pain, Cough, Runny Nose & Sneezing 0% Artificial Additives, Dyes, Artificial Sweeteners, Common Allergens Made with Real Agave + Blueberry Flavoring TWO - 4 FL OZ (118 mL) BOTTLES TOTAL - 8 FL OZ (236 mL) 10066-GNX carton_R-20251226" ], "set_id": "213fe898-dace-9a0f-e063-6394a90afd64", "id": "52ea76d4-2910-0139-e063-6294a90a3569", "effective_time": "20260528", "version": "6", "openfda": { "application_number": [ "M012" ], "brand_name": [ "Daytime and Nighttime Kids Multi-Symptom Cold and Flu combo pack" ], "generic_name": [ "ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL" ], "manufacturer_name": [ "Genexa Inc." ], "product_ndc": [ "69676-0092" ], "product_type": [ "HUMAN OTC DRUG" ], "rxcui": [ "2693770", "2693775", "2693776" ], "spl_id": [ "52ea76d4-2910-0139-e063-6294a90a3569" ], "spl_set_id": [ "213fe898-dace-9a0f-e063-6394a90afd64" ], "package_ndc": [ "69676-0092-3" ], "is_original_packager": [ true ] } } ] }