{
"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",
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{
"spl_product_data_elements": [
"Maximum Strength Severe Congestion and Cough Dextromethorphan HBr, Guaifenesin, and 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 DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE"
],
"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 the impulse to cough to help you get to sleep nasal congestion due to a cold"
],
"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 persistent headache. 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. (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 persistent headache. 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. (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 8 mg low sodium store at room temperature do not refrigerate"
],
"inactive_ingredient": [
"Inactive ingredients anhydrous citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavors, 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 21130-738-06 Compare to Mucinex® Fast- Max® Maximum Strength Severe Congestion & Cough Active Ingredients* Maximum Strength Severe Congestion & Cough Dextromethorphan HBr - Cough Suppressant Guaifenesin - Expectorant Phenylephrine HCl - Nasal Decongestant Control Cough Relieves Nasal and Chest Congestion Thins & loosens mucus For Ages 12+ 6 FL OZ (180 mL) Tamper evident: do not use if printed seal under cap is broken or missing. *This product is not manufactured or distributed by RB Health (US) LLC, the distributor of Mucinex ® and Fast-Max ® Maximum Strength Severe Congestion & Cough. DISTRIBUTED BY BETTER LIVING BRANDS LLC P.O. BOX 99, PLEASANTON, CA 94566-0009 1-888-723-3929 www.betterlivingbrandsLLC.com OUR PROMISE, QUALITY & SATISFACTION 100% GUARANTEED OR YOUR MONEY BACK Severe Congestion and Cough Max Strength"
],
"set_id": "013b94a1-26c7-4371-981a-d1b9d7fd1c98",
"id": "424a8ef2-038a-06ed-e063-6394a90a640d",
"effective_time": "20251029",
"version": "7",
"openfda": {
"application_number": [
"M012"
],
"brand_name": [
"Maximum Strength Severe Congestion and Cough"
],
"generic_name": [
"DEXTROMETHORPHAN HBR, GUAIFENESIN, AND PHENYLEPHRINE HCL"
],
"manufacturer_name": [
"SAFEWAY"
],
"product_ndc": [
"21130-738"
],
"product_type": [
"HUMAN OTC DRUG"
],
"route": [
"ORAL"
],
"substance_name": [
"DEXTROMETHORPHAN HYDROBROMIDE",
"GUAIFENESIN",
"PHENYLEPHRINE HYDROCHLORIDE"
],
"rxcui": [
"1043543"
],
"spl_id": [
"424a8ef2-038a-06ed-e063-6394a90a640d"
],
"spl_set_id": [
"013b94a1-26c7-4371-981a-d1b9d7fd1c98"
],
"package_ndc": [
"21130-738-06"
],
"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"
]
}
}
]
}