{
"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": "2026-10-02",
"results": {
"skip": 0,
"limit": 1,
"total": 1
}
},
"results": [
{
"spl_product_data_elements": [
"CVS Maximum Strength Severe Congestion and Cough dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride dextromethorphan hydrobromide dextromethorphan guaifenesin guaifenesin phenylephrine hydrochloride phenylephrine anhydrous citric acid D&C YELLOW NO. 10 edetate disodium FD&C Blue NO. 1 POTASSIUM CITRATE propylene glycol propyl gallate water sodium benzoate sorbitol sucralose xanthan gum Cooling Menthol"
],
"spl_unclassified_section": [
"Drug Facts"
],
"active_ingredient": [
"Active ingredients (in each 20 mL) Purposes Dextromethorphan HBr 20 mg Cough suppressant Guaifenesin 400 mg Expectorant Phenylephrine HCl 10 mg Nasal decongestant"
],
"active_ingredient_table": [
"
"
],
"indications_and_usage": [
"Uses • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive • temporarily relieves: • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants • the intensity of coughing • nasal congestion due to a cold • temporarily helps you cough less"
],
"warnings": [
"Warnings Do not use • 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 • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema • cough that occurs with too much phlegm (mucus) When using this product do not use more than directed Stop use and ask a doctor if • nervousness, dizziness or sleeplessness occur • symptoms do not get better within 7 days or occur with fever • 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 at (1-800-222-1222)."
],
"do_not_use": [
"Do not use • 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 • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema • cough that occurs with too much phlegm (mucus)"
],
"when_using": [
"When using this product do not use more than directed"
],
"stop_use": [
"Stop use and ask a doctor if • nervousness, dizziness or sleeplessness occur • symptoms do not get better within 7 days or occur with fever • 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."
],
"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 at (1-800-222-1222)."
],
"dosage_and_administration": [
"Directions • 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 • very low sodium • store at room temperature • do not refrigerate • dosing cup provided Inactive Ingredients anhydrous citric acid, D&C Yellow No. 10, edetate disodium, FD&C Blue No. 1, flavor, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum."
],
"inactive_ingredient": [
"Inactive Ingredients anhydrous citric acid, D&C Yellow No. 10, edetate disodium, FD&C Blue No. 1, flavor, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum."
],
"questions": [
"Questions or comments? 1-866-467-2748"
],
"package_label_principal_display_panel": [
"PRINCIPAL DISPLAY PANEL NDC# 69842-767-06 Compare to Mucinex ® Fast-Max ® Maximum Strength Severe Congestion & Cough Clear and Cool ® Active Ingredients* Maximum Strength Severe Congestion & Cough Dextromethorphan HBr Cough Suppressant Guaifenesin Expectorant Phenylephrine HCl Nasal Decongestant 1. Controls Cough, 2. Relieves Nasal & Chest Congestion 3. Thins & Loosens Mucus Cooling Menthol Flavor Naturally and Artificially Flavored 6 FL OZ (180 mL) For Ages 12+ Tamper evident: do not use if printed seal under cap is broken or missing. Distributed by: *This product is not manufactured or distributed by Reckitt Benckiser, the distributor of Mucinex® Fast -Max® Maximum Strength Severe Congestion & Cough Clear & Cool™. CVS Maximum Strength Severe Congestion & cough"
],
"set_id": "bfb3d021-f65f-499c-bbb1-c1aceb7a7bf9",
"id": "5768c53a-cbb8-4503-9e6a-270a40bf53d5",
"effective_time": "20260819",
"version": "8",
"openfda": {
"application_number": [
"M012"
],
"brand_name": [
"CVS Maximum Strength Severe Congestion and Cough"
],
"generic_name": [
"DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE"
],
"manufacturer_name": [
"CVS PHARMACY, INC"
],
"product_ndc": [
"69842-767"
],
"product_type": [
"HUMAN OTC DRUG"
],
"route": [
"ORAL"
],
"substance_name": [
"DEXTROMETHORPHAN HYDROBROMIDE",
"GUAIFENESIN",
"PHENYLEPHRINE HYDROCHLORIDE"
],
"rxcui": [
"1043543"
],
"spl_id": [
"5768c53a-cbb8-4503-9e6a-270a40bf53d5"
],
"spl_set_id": [
"bfb3d021-f65f-499c-bbb1-c1aceb7a7bf9"
],
"package_ndc": [
"69842-767-06"
],
"is_original_packager": [
true
],
"nui": [
"N0000193956",
"N0000008867",
"N0000009560"
],
"pharm_class_epc": [
"Expectorant [EPC]"
],
"pharm_class_pe": [
"Decreased Respiratory Secretion Viscosity [PE]",
"Increased Respiratory Secretions [PE]"
],
"unii": [
"9D2RTI9KYH",
"495W7451VQ",
"04JA59TNSJ"
]
}
}
]
}