{ "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": 3 } }, "results": [ { "spl_product_data_elements": [ "Daytime and Nighttime Severe Honey Cold and Flu Daytime - Acetaminophen. Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl and Nightime - Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Doxylamine succinate Daytime Severe Honey Cold and Flu Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL CITRIC ACID MONOHYDRATE D&C YELLOW NO. 10 XANTHAN GUM FD&C YELLOW NO. 6 SODIUM CITRATE SUCRALOSE GLYCERIN SACCHARIN SODIUM FD&C GREEN NO. 3 SORBITOL WATER SODIUM BENZOATE FD&C RED NO. 40 ACETAMINOPHEN ACETAMINOPHEN GUAIFENESIN GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE Nighttime Severe Honey Cold and Flu Acetaminophen, Dextromethrophan, Doxylamine succinate, Phenylephrine HCl POLYETHYLENE GLYCOL, UNSPECIFIED SUCRALOSE SORBITOL CITRIC ACID MONOHYDRATE SODIUM BENZOATE FD&C YELLOW NO. 6 GLYCERIN PROPYLENE GLYCOL WATER FD&C RED NO. 40 XANTHAN GUM D&C YELLOW NO. 10 SACCHARIN SODIUM SODIUM CITRATE FD&C GREEN NO. 3 ACETAMINOPHEN ACETAMINOPHEN DOXYLAMINE SUCCINATE DOXYLAMINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE" ], "spl_unclassified_section": [ "Severe Nighttime Honey Cold & Flu", "Drug Facts", "Severe Daytime Honey Cold & Flu", "Drug Facts" ], "active_ingredient": [ "Active ingredients (in each 15 mL) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg Purpose Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant", "Active ingredients (in each 15 mL) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg Purpose Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant" ], "purpose": [ "Purpose Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant", "Purpose Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant" ], "indications_and_usage": [ "Uses temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation cough to help you sleep minor aches & pains headache fever sore throat runny nose & sneezing reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage", "Uses temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation minor aches & pains headache fever sore throat reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive." ], "warnings": [ "Warnings Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult takes more than 4 doses (30 mL each) in 24 hrs, which is the maximum daily amount for this product child takes more than 4 doses (15 mL each) in 24 hrs, which is the maximum daily amount for this product taken with other drugs containing acetaminophen adult has 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. to make a child sleepy Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes glaucoma 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 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 you get nervous, dizzy or sleepless pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults) 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 (1-800-222-1222) right away. Quick 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 adult takes more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product child takes more than 4 doses (15 mL each) in 24 hours, which is the maximum daily amount for this product taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks daily 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 is 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 heart disease high blood pressure thyroid disease diabetes trouble urinating due to enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, 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 you get nervous, dizzy or sleepless pain, nasal congestion or cough gets worse or lasts more than 5 days (children) 7 days (adults) 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 (1-800-222-1222) right away. Quick 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 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. to make a child sleepy", "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_doctor": [ "Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes glaucoma 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 trouble urinating due to enlarged prostate gland", "Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin.", "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin" ], "when_using": [ "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", "When using this product, do not use more than directed" ], "stop_use": [ "Stop use and ask a doctor if you get nervous, dizzy or sleepless pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults) 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 you get nervous, dizzy or sleepless pain, nasal congestion or cough gets worse or lasts more than 5 days (children) 7 days (adults) 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 (1-800-222-1222) right away. Quick 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 a Poison Control Center (1-800-222-1222) right away. Quick 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 take only as directed only use the dose cup provided do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 4 hrs children 6 to under 12 yrs 15 mL every 4 hrs children 4 to under 6 yrs do not use unless directed by a doctor children under 4 yrs do not use", "Directions take only as directed only use the dose cup provided do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 4 hrs children 6 to under 12 yrs 15 mL every 4 hrs children 4 to under 6 yrs ask a doctor children under 4 yrs do not use" ], "dosage_and_administration_table": [ "
adults & children 12 yrs & over30 mL every 4 hrs
children 6 to under 12 yrs15 mL every 4 hrs
children 4 to under 6 yrsdo not use unless directed by a doctor
children under 4 yrsdo not use
", "
adults & children 12 yrs & over30 mL every 4 hrs
children 6 to under 12 yrs 15 mL every 4 hrs
children 4 to under 6 yrsask a doctor
children under 4 yrsdo not use
" ], "storage_and_handling": [ "Other information each 15 mL contains: sodium 14 mg Store at no greater than 25°C and do not refrigerate.", "Other information each 15 mL contains: sodium 14 mg Store at no greater than 25°C and do not refrigerate" ], "inactive_ingredient": [ "Inactive ingredients citric acid monohydrate, D&C yellow no. 10, FD&C green no. 3, FD&C red no. 40, FD&C yellow no. 6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution, sucralose, xanthan gum", "Inactive ingredients citric acid monohydrate, D&C yellow no. 10, FD&C green no. 3, FD&C red no. 40, FD&C yellow no. 6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution, sucralose, xanthan gum" ], "questions": [ "Questions or comments? Call 1-800-910-6874", "Questions or comments? Call 1-800-910-6874" ], "package_label_principal_display_panel": [ "daytime-nighttime-label nighttime-label daytime-label" ], "set_id": "08fd1513-30ab-15da-e063-6394a90ab57d", "id": "1b613025-ee6b-d95d-e063-6294a90a5ac4", "effective_time": "20240621", "version": "2", "openfda": { "application_number": [ "M012" ], "brand_name": [ "Daytime and Nighttime Severe Honey Cold and Flu" ], "generic_name": [ "DAYTIME - ACETAMINOPHEN. DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL AND NIGHTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATE" ], "manufacturer_name": [ "TARGET CORPORATION" ], "product_ndc": [ "11673-328" ], "product_type": [ "HUMAN OTC DRUG" ], "rxcui": [ "1369842", "1431245", "2637731" ], "spl_id": [ "1b613025-ee6b-d95d-e063-6294a90a5ac4" ], "spl_set_id": [ "08fd1513-30ab-15da-e063-6394a90ab57d" ], "package_ndc": [ "11673-328-02" ], "is_original_packager": [ true ] } } ] }