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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": "2026-06-09",
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{
"spl_product_data_elements": [
"MUCINEX FAST-MAX NIGHTTIME COLD AND FLU Acetaminophen, Dextromethorphan Hydrobromide, Triprolidine Hydrochloride GLYCERIN AMMONIUM GLYCYRRHIZATE ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 PROPYLENE GLYCOL SODIUM BENZOATE SORBITOL SUCRALOSE TRIACETIN WATER XANTHAN GUM ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN TRIPROLIDINE HYDROCHLORIDE TRIPROLIDINE"
],
"spl_unclassified_section": [
"Drug Facts",
"Dist. by: RB Health (US) Parsippany, NJ 07054-0224"
],
"active_ingredient": [
"Active ingredients (in each 20 mL) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan HBr 20 mg Cough suppressant Triprolidine HCl 2.5 mg Antihistamine"
],
"active_ingredient_table": [
"
"
],
"indications_and_usage": [
"Uses temporarily relieves these common cold and flu symptoms: cough minor aches and pains sore throat headache runny nose sneezing itching of the nose or throat itchy, watery eyes due to hay fever 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 4000 mg 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. 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 an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma, 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 use caution when driving a motor vehicle or operating machinery 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 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. 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."
],
"ask_doctor": [
"Ask a doctor before use if you have liver disease glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma, 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 use caution when driving a motor vehicle or operating machinery"
],
"stop_use": [
"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 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."
],
"dosage_and_administration": [
"Directions do not take more than directed (see Overdose warning ) do not take more than 4 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 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 16 mg store at 20-25°C (68-77°F) do not refrigerate"
],
"inactive_ingredient": [
"Inactive ingredients Inactive ingredients ammonium glycyrrhizate, anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin (soy), propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum"
],
"questions": [
"Questions? 1-866-MUCINEX (1-866-682-4639) You may also report side effects to this phone number."
],
"package_label_principal_display_panel": [
"PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label NDC 72854-143-66 Mucinex® NIGHTTIME COLD & FLU Acetaminophen – Pain Reliever/Fever Reducer Dextromethorphan HBr – Cough Suppressant Triprolidine HCl – Antihistamine NIGHT TIME ✓COUGH ✓FEVER ✓SORE THROAT ✓RUNNY NOSE ✓SNEEZING 6 FL OZ (180 mL) FOR AGES 12+ carton label back label label 2"
],
"set_id": "3a24b06c-00a6-c2ef-e063-6294a90a4d72",
"id": "521a96af-66c8-49cb-e063-6394a90a1e4d",
"effective_time": "20260518",
"version": "5",
"openfda": {
"application_number": [
"M012"
],
"brand_name": [
"MUCINEX FAST-MAX NIGHTTIME COLD AND FLU"
],
"generic_name": [
"ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDE"
],
"manufacturer_name": [
"Reckitt Benckiser LLC"
],
"product_ndc": [
"72854-143"
],
"product_type": [
"HUMAN OTC DRUG"
],
"route": [
"ORAL"
],
"substance_name": [
"ACETAMINOPHEN",
"DEXTROMETHORPHAN HYDROBROMIDE",
"TRIPROLIDINE HYDROCHLORIDE"
],
"rxcui": [
"2173667"
],
"spl_id": [
"521a96af-66c8-49cb-e063-6394a90a1e4d"
],
"spl_set_id": [
"3a24b06c-00a6-c2ef-e063-6294a90a4d72"
],
"package_ndc": [
"72854-143-66"
],
"is_original_packager": [
true
],
"upc": [
"0363824014708"
],
"unii": [
"362O9ITL9D",
"9D2RTI9KYH",
"YAN7R5L890"
]
}
}
]
}