{
"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": 21
}
},
"results": [
{
"spl_product_data_elements": [
"Maximum Strength Nighttime Cold and Flu Acetaminophen , Diphenhydramine HCl,Phenylephrine HCl ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 POTASSIUM CITRATE PROPYLENE GLYCOL PROPYL GALLATE WATER SODIUM BENZOATE SORBITOL SUCRALOSE XANTHAN GUM ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE"
],
"spl_unclassified_section": [
"Drug Facts"
],
"active_ingredient": [
"Active ingredients (in each 20 mL) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Diphenhydramine HCl 25 mg Antihistamine/cough suppressant Phenylephrine HCl 10 mg Nasal decongestant"
],
"active_ingredient_table": [
"
"
],
"indications_and_usage": [
"Uses temporarily relieves these common cold and flu symptoms: cough nasal congestion minor aches and pains sore throat headache runny nose sneezing temporarily reduces fever controls cough to help you get to sleep"
],
"warnings": [
"Warnings Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 6 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 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 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 drug containing diphenhydramine, even one used on the skin 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 an enlarged prostate gland glaucoma a breathing problem such as emphysema or chronic bronchitis 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 or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, 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 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. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away 1-800-222-1222. 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. with any other drug containing diphenhydramine, even one used on the skin 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 trouble urinating due to an enlarged prostate gland glaucoma a breathing problem such as emphysema or chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus)"
],
"ask_doctor_or_pharmacist": [
"Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers"
],
"when_using": [
"When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery"
],
"stop_use": [
"Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, 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 fever, 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."
],
"keep_out_of_reach_of_children": [
"Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away 1-800-222-1222. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms."
],
"overdosage": [
"Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away 1-800-222-1222. 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 do not take more than directed (see Overdose warning) 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 mL= milliliter adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours children under 12 years of age: do not use"
],
"storage_and_handling": [
"Other information each 20 mL contains: sodium 6 mg low sodium store at room temperature do not refrigerate dosing cup provided"
],
"inactive_ingredient": [
"Inactive ingredients anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, natural and artificial flavor, potassium citrate ,propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum."
],
"questions": [
"Questions or comments? 1-888-287-1915"
],
"package_label_principal_display_panel": [
"PRINCIPAL DISPLAY PANEL - NDC# 30142-736-06 Compare to Mucinex ® Fast-Max ® Maximum Strength Might Time Cold & Flu Active Ingredients Maximum Strength Night Time Cold & Flu Acetaminophen Pain Reliever/Fever Reducer Diphenhydramine HCl Antihistamine/Cough Suppressant Phenylephrine HCl Nasal Decongestant Relieves: Sore Throat; Itchy Throat-Cough Nasal Congestion – Sneezing & Runny Nose Headache – Body Pain For Ages 12+ 6 FL OZ (180 mL) *This product is not manufactured or distributed by Reckitt Benckiser, the distributor of Mucinex ® Fast- Max ® Maximum Strength Nighttime Cold & Flu Tamper evident: do not use if printed seal under cap is broken or missing. ‡Maximum Strength per 4 hour dose. Distributed by: Maximum Strength Nighttime Cold & Flu"
],
"set_id": "058b2021-8a61-40b0-8a2e-a784d2b847fb",
"id": "3c28fa93-4a04-9245-e063-6394a90a6871",
"effective_time": "20250812",
"version": "7",
"openfda": {
"application_number": [
"M012"
],
"brand_name": [
"Maximum Strength Nighttime Cold and Flu"
],
"generic_name": [
"ACETAMINOPHEN , DIPHENHYDRAMINE HCL,PHENYLEPHRINE HCL"
],
"manufacturer_name": [
"THE KROGER CO"
],
"product_ndc": [
"30142-736"
],
"product_type": [
"HUMAN OTC DRUG"
],
"route": [
"ORAL"
],
"substance_name": [
"ACETAMINOPHEN",
"DIPHENHYDRAMINE HYDROCHLORIDE",
"PHENYLEPHRINE HYDROCHLORIDE"
],
"rxcui": [
"1375932"
],
"spl_id": [
"3c28fa93-4a04-9245-e063-6394a90a6871"
],
"spl_set_id": [
"058b2021-8a61-40b0-8a2e-a784d2b847fb"
],
"package_ndc": [
"30142-736-06"
],
"is_original_packager": [
true
],
"unii": [
"362O9ITL9D",
"TC2D6JAD40",
"04JA59TNSJ"
]
}
}
]
}