{
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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": [
"Pain and Sinus Reliever Acetaminophen and Phenylephrine ACETAMINOPHEN ACETAMINOPHEN PHENYLEPHRINE PHENYLEPHRINE STARCH, CORN CROSPOVIDONE, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED STEARIC ACID AZ261"
],
"spl_unclassified_section": [
"Drug Facts"
],
"active_ingredient": [
"Active ingredient (In Each Tablet) Purpose Acetaminophen 500 mg pain reliever/fever reducer Phenylephrine 5 mg nasal decongestant"
],
"active_ingredient_table": [
"
"
],
"indications_and_usage": [
"Use temporarily relieves: headache sinus pain nasal and sinus congestion minor aches and pains fever"
],
"warnings": [
"Warnings Liver Warning This product contains acetaminophen. Severe liver damage may occur if you take: more than 8 tablets or 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen (prescription or nonprescription) 3 or more alcoholic drinks every day 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 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 two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before using this product for more than 3 days for fever unless directed by a doctor with any other product containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a pharmacist for more than 10 days for pain unless directed by a doctor Ask a doctor before use if you have liver disease, heart disease, high blood pressure, thyroid disease, diabetes or difficulty in urination due to enlargement of the prostate gland. Ask a doctor before use if you are taking the blood thinning drug warfarin. Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur 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 Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 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 two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before using this product for more than 3 days for fever unless directed by a doctor with any other product containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a pharmacist for more than 10 days for pain unless directed by a doctor"
],
"ask_doctor": [
"Ask a doctor before use if you have liver disease, heart disease, high blood pressure, thyroid disease, diabetes or difficulty in urination due to enlargement of the prostate gland."
],
"ask_doctor_or_pharmacist": [
"Ask a doctor before use if you are taking the blood thinning drug warfarin."
],
"stop_use": [
"Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur 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 Adults and children 12 years of age and older: Take 2 tablets every 6 hours do not exceed 8 tablets in 24 hours Children under 12 years of age: Ask a doctor"
],
"storage_and_handling": [
"Other information store at room temperature between 20-25 °C (68-77° F) do not use if packet is opened or torn"
],
"inactive_ingredient": [
"Inactive ingredients corn starch, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid"
],
"questions": [
"Questions? 1-866-651-3660 Monday-Friday 8:00am-5:00pm EST"
],
"package_label_principal_display_panel": [
"PRINCIPAL DISPLAY PANEL - 250 Tablet Packet Box Product #1194 Pain & Sinus Reliever Active ingredient: Acetaminophen Phenylephrine Pain Reliever/Nasal Decongestant Formulated for relief from sinus pressure and nasal congestion Aspirin free non-drowsy formula These quality comfort tablets are formulated and packaged for use in the workplace and meet ANSI Z308.1-2021 standards. They are sealed in tamper evident packets for safety and convenience. 250 Tablets • 2 Tablets Per Packet PRINCIPAL DISPLAY PANEL - 250 Tablet Packet Box"
],
"set_id": "249373c6-f56f-4bd3-9cef-98b7ee73457d",
"id": "750f244f-b808-4801-a278-bc6c4c8aa455",
"effective_time": "20240514",
"version": "1",
"openfda": {
"application_number": [
"M012"
],
"brand_name": [
"Pain and Sinus Reliever"
],
"generic_name": [
"ACETAMINOPHEN AND PHENYLEPHRINE"
],
"manufacturer_name": [
"JHK DBA American Safety & First Aid"
],
"product_ndc": [
"73598-1194"
],
"product_type": [
"HUMAN OTC DRUG"
],
"route": [
"ORAL"
],
"substance_name": [
"ACETAMINOPHEN",
"PHENYLEPHRINE"
],
"rxcui": [
"1101534"
],
"spl_id": [
"750f244f-b808-4801-a278-bc6c4c8aa455"
],
"spl_set_id": [
"249373c6-f56f-4bd3-9cef-98b7ee73457d"
],
"package_ndc": [
"73598-1194-1"
],
"is_original_packager": [
true
],
"nui": [
"N0000186105",
"N0000009917"
],
"pharm_class_epc": [
"alpha-1 Adrenergic Agonist [EPC]"
],
"pharm_class_moa": [
"Adrenergic alpha1-Agonists [MoA]"
],
"unii": [
"362O9ITL9D",
"1WS297W6MV"
]
}
}
]
}