{
"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": {
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"results": [
{
"spl_product_data_elements": [
"Mucinex Fast-Max Severe Congestion and Cough Guaifenesin, Phenylephrine Hydrochloride, and Dextromethorphan Hydrobromide STARCH, CORN FD&C BLUE NO. 2 FD&C RED NO. 40 MAGNESIUM STEARATE MALTODEXTRIN MICA MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE, UNSPECIFIED SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID TALC TITANIUM DIOXIDE GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN SRS"
],
"spl_unclassified_section": [
"Drug Facts",
"Dist. by: Reckitt Benckiser, Parsippany, NJ 07054-0224"
],
"active_ingredient": [
"Active ingredients (in each caplet) Purposes Dextromethorphan HBr 10 mg Cough suppressant Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 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 diabetes high blood pressure thyroid disease 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 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. In case of overdose, get medical help or contact a Poison Control Center right away."
],
"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 diabetes high blood pressure thyroid disease 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 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. In case of overdose, get medical help or contact a Poison Control Center right away."
],
"dosage_and_administration": [
"Directions do not take more than 12 caplets in any 24-hour period adults and children 12 years of age and over: take 2 caplets every 4 hours children under 12 years of age: do not use"
],
"storage_and_handling": [
"Other information store between 20-25°C (68-77°F)"
],
"inactive_ingredient": [
"Inactive ingredients corn starch, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, magnesium stearate, maltodextrin, mica, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide"
],
"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 - 20 Caplet Blister Pack Carton Label back label"
],
"set_id": "1991d5ee-fc90-4070-8965-cd6f4abc45cf",
"id": "51b45cdb-42b6-7a6f-e063-6294a90a5039",
"effective_time": "20260513",
"version": "8",
"openfda": {
"application_number": [
"M012"
],
"brand_name": [
"Mucinex Fast-Max Severe Congestion and Cough"
],
"generic_name": [
"GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE"
],
"manufacturer_name": [
"Reckitt Benckiser LLC"
],
"product_ndc": [
"63824-515"
],
"product_type": [
"HUMAN OTC DRUG"
],
"route": [
"ORAL"
],
"substance_name": [
"DEXTROMETHORPHAN HYDROBROMIDE",
"GUAIFENESIN",
"PHENYLEPHRINE HYDROCHLORIDE"
],
"rxcui": [
"1372652"
],
"spl_id": [
"51b45cdb-42b6-7a6f-e063-6294a90a5039"
],
"spl_set_id": [
"1991d5ee-fc90-4070-8965-cd6f4abc45cf"
],
"package_ndc": [
"63824-515-01",
"63824-515-20"
],
"is_original_packager": [
true
],
"upc": [
"0363824193205"
],
"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"
]
}
}
]
}