{
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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": "2026-10-02",
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{
"spl_product_data_elements": [
"CVS Severe Congestion and Pain Relief ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE ACETAMINOPHEN ACETAMINOPHEN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE 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"
],
"spl_unclassified_section": [
"Drug Facts"
],
"active_ingredient": [
"Active ingredients (in each 20 mL) Purposes Acetaminophen 650 mg Pain reliever Guaifenesin 400 mg Expectorant Phenylephrine HCl 10 mg Nasal decongestant"
],
"active_ingredient_table": [
"| Active ingredients (in each 20 mL) | Purposes |
|---|
| Acetaminophen 650 mg | Pain reliever |
| Guaifenesin 400 mg | Expectorant |
| Phenylephrine HCl 10 mg | Nasal decongestant |
"
],
"purpose": [
"Active ingredients (in each 20 mL) Purposes Acetaminophen 650 mg Pain reliever Guaifenesin 400 mg Expectorant Phenylephrine HCl 10 mg Nasal decongestant"
],
"purpose_table": [
"| Active ingredients (in each 20 mL) | Purposes |
|---|
| Acetaminophen 650 mg | Pain reliever |
| Guaifenesin 400 mg | Expectorant |
| Phenylephrine HCl 10 mg | Nasal decongestant |
"
],
"indications_and_usage": [
"Uses ▪ temporarily relieves: ▪ nasal congestion ▪ headache ▪ minor aches and pains ▪ sinus congestion and pressure ▪ temporarily promotes nasal and/or sinus drainage ▪ helps loosens phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive"
],
"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. 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 ▪ 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) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not use more than directed 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 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 at 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. ▪ 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 ▪ 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"
],
"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 • 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 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 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 ▪ 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 ▪ 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 - 180 mL Bottle Label Compare to the active ingredients Maximum Strength* Mucinex® Sinus- Max ® Severe Congestion & Pain** NDC 63824-261-66 ADULT Severe Congestion Pain Reliever Acetaminophen – Pain Reliever GUAIFENESIN – Expectorant PHENYLEPHRINE HCl – Nasal Decongestant MAXIMUM STRENGTH* Multi-Symptom • Clears Sinus Congestion • Relieves Headache • Thins & Loosens Mucus For Ages 12 Years & Over 6 FL OZ (180mL) TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS BROKEN OR MISSING. *Per 4- hour dose Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02985 © 2020 CVS/pharmacy CVS.com 1-800-SHOP CVS V-12431 *This product is not manufactured or distributed by RB Health, the distributor of Maximum Strength* Mucinex® Sinus-Max® Severe Congestion & Pain. CVS Sever Congestion Relief Acetaminophen"
],
"set_id": "5a8e4320-bae1-4831-b66b-9babfe8888d6",
"id": "e8ea3a44-7cbf-4c7d-af74-f95ae1e2ed9c",
"effective_time": "20260819",
"version": "8",
"openfda": {
"application_number": [
"M012"
],
"brand_name": [
"CVS Severe Congestion and Pain Relief"
],
"generic_name": [
"ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE"
],
"manufacturer_name": [
"CVS"
],
"product_ndc": [
"69842-717"
],
"product_type": [
"HUMAN OTC DRUG"
],
"route": [
"ORAL"
],
"substance_name": [
"ACETAMINOPHEN",
"GUAIFENESIN",
"PHENYLEPHRINE HYDROCHLORIDE"
],
"rxcui": [
"1116568"
],
"spl_id": [
"e8ea3a44-7cbf-4c7d-af74-f95ae1e2ed9c"
],
"spl_set_id": [
"5a8e4320-bae1-4831-b66b-9babfe8888d6"
],
"package_ndc": [
"69842-717-06"
],
"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": [
"362O9ITL9D",
"495W7451VQ",
"04JA59TNSJ"
]
}
}
]
}