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"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",
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{
"spl_product_data_elements": [
"CVS DT and NT Combo Pack Cold and Flu Acetaminophen, Phenylephrine Hydrochloride, and Doxylamine Succinate CVS DayTime Cold and Flu Relief Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C YELLOW NO. 6 GLYCERIN MENTHOL, UNSPECIFIED FORM POTASSIUM CITRATE PROPYL GALLATE PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CHLORIDE SORBITOL SUCRALOSE XANTHAN GUM ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CVS NightTime Cold and Flu Relief Acetaminophen, Doxylamine Succinate, and Dextromethorphan Hydrobromide ANHYDROUS CITRIC ACID D&C YELLOW NO. 10 EDETATE DISODIUM FD&C GREEN NO. 3 FD&C YELLOW NO. 6 PROPYL GALLATE PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCRALOSE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE"
],
"spl_unclassified_section": [
"CVS DayTime Cold & Flu Relief",
"CVS NIGHTTIME COLD & FLU RELIEF",
"Distributed By:"
],
"active_ingredient": [
"Active ingredients (in each 15 mL) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg Purpose Pain reliever/Fever reducer Cough suppressant Nasal decongestant",
"Active ingredients (in each 30 mL) Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg Purpose Pain reliever/Fever reducer Cough suppressant Antihistamine"
],
"purpose": [
"Purpose Pain reliever/Fever reducer Cough suppressant Nasal decongestant",
"Purpose Pain reliever/Fever reducer Cough suppressant Antihistamine"
],
"indications_and_usage": [
"Uses temporarily relieves common cold/flu symptoms: nasal congestion cough due to minor throat & bronchial irritation minor aches & pains headache fever sore throat",
"Uses temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation minor aches & pains headache fever sore throat runny nose & sneezing"
],
"warnings": [
"Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take 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 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 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, or emphysema A sodium-restricted diet 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) or 7 days (adult) 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. 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 you take more than 4 doses in 24 hours, which is the maximum daily amount for this product taken 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 glaucoma Trouble urinating due to enlarged prostate gland Cough that occurs with too much phlegm (mucus) A breathing problem or chronic cough such as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if you are Taking sedatives or tranquilizers Taking the blood thinning drug warfarin When using this product 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 & 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. 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.",
"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 glaucoma Trouble urinating due to enlarged prostate gland Cough that occurs with too much phlegm (mucus) A breathing problem or chronic cough such as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if you are Taking sedatives or tranquilizers Taking the blood thinning drug warfarin"
],
"ask_doctor": [
"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, or emphysema A sodium-restricted diet",
"Ask a doctor before use if you have Liver disease glaucoma Trouble urinating due to enlarged prostate gland Cough that occurs with too much phlegm (mucus) A breathing problem or chronic cough such as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if you are Taking sedatives or tranquilizers Taking the blood thinning drug warfarin"
],
"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"
],
"when_using": [
"When using this product, do not use more than directed.",
"When using this product 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 & tranquilizers may increase drowsiness"
],
"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 (adult) 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."
],
"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. 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 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 hours Children 6 to under 12 yrs 15 mL every 4 hours children 4 to under 12 yrs ask 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 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 & over
30 mL every 4 hours
Children 6 to under 12 yrs
15 mL every 4 hours
children 4 to under 12 yrs
ask a doctor
children under 4 yrs
do not use
",
"
adults & children 12 yrs & over
30 mL every 4 hours
children 4 to under 12 yrs
ask a doctor
children under 4 yrs
do not use
"
],
"storage_and_handling": [
"Other information each 15 mL contains : sodium 42 mg store at room temperature Do not refrigerate.",
"Other information each 30 mL contains: sodium 16 mg Store at room temperature Do not refrigerate"
],
"inactive_ingredient": [
"Inactive ingredients Anhydrous citric acid, disodium edetate, FD&C Yellow No. 6, flavor, glycerin, menthol, potassium citrate, propyl gallate, purified water, sodium benzoate, sodium chloride, sorbitol, sucralose, xanthan gum",
"Inactive ingredients Citric acid, D&C Yellow No. 10, disodium edetate, FD&C Green No.3, FD&C Yellow no 6, flavor, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose"
],
"questions": [
"Questions? 1-866-467-2748",
"Questions? 1-866-467-2748"
],
"package_label_principal_display_panel": [
"PRINCIPAL DISPLAY PANEL - Kit Carton Compare to the active ingredients in Vicks®DayQuil™ Cold & Flu* NDC# 51316-618-12 DayTime Cold & Flu Relief Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl Headache, Fever, Sore Throat, Minor Aches & Pains Nasal Congestion & Sinus Pressure Cough Compare to the active ingredients in Vicks®NyQuil™ Cold & Flu* NightTime Cold & Flu Relief Acetaminophen, Dextromethorphan HBr Dextromethorphan HBr headache, Fever, Sore Throat, Minor Aches & Pains Sneezing, Runny Nose Cough Original Flavor Tamper Evident: Do not use if imprinted shrink band is missing or broken. TWO BOTTLES, 12 FL OZ (354 mL) each; TOTAL 24 FL OZ (708 mL) *These product is not manufactured or distributed by Procter & Gamble, distributor of Vicks®Dayquil™ and Vicks® Nyquil™ Cold & flu. CVS Daytime and NightTime Cold And Flu relief 708 mL (COMBO PACK)"
],
"set_id": "360c8c62-0945-4031-b291-d40c4270b940",
"id": "4598f0d9-27c1-2647-e063-6394a90ad6ed",
"effective_time": "20251210",
"version": "6",
"openfda": {
"application_number": [
"M012"
],
"brand_name": [
"CVS DT and NT Combo Pack Cold and Flu"
],
"generic_name": [
"ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE"
],
"manufacturer_name": [
"CVS PHARMACY"
],
"product_ndc": [
"51316-618"
],
"product_type": [
"HUMAN OTC DRUG"
],
"rxcui": [
"1043400",
"1113705",
"2637726"
],
"spl_id": [
"4598f0d9-27c1-2647-e063-6394a90ad6ed"
],
"spl_set_id": [
"360c8c62-0945-4031-b291-d40c4270b940"
],
"package_ndc": [
"51316-618-12",
"51316-620-12",
"51316-619-12"
],
"is_original_packager": [
true
]
}
}
]
}