{ "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": "2026-06-09", "results": { "skip": 0, "limit": 1, "total": 22 } }, "results": [ { "spl_product_data_elements": [ "Sinus Pressure and Pain PE ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE SILICON DIOXIDE CROSCARMELLOSE SODIUM CROSPOVIDONE, UNSPECIFIED FD&C YELLOW NO. 6 ALUMINUM OXIDE FERRIC OXIDE YELLOW MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE, UNSPECIFIED STARCH, CORN STEARIC ACID TALC TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE AAA;1120" ], "spl_unclassified_section": [ "Drug Facts" ], "active_ingredient": [ "Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Phenylephrine HCl 5 mg Nasal decongestant" ], "active_ingredient_table": [ "
Active ingredients (in each caplet)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Phenylephrine HCl 5 mgNasal decongestant
" ], "purpose": [ "Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Phenylephrine HCl 5 mg Nasal decongestant" ], "purpose_table": [ "
Active ingredients (in each caplet)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Phenylephrine HCl 5 mgNasal decongestant
" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold: sinus congestion and pressure headache minor aches and pains nasal congestion promotes sinus drainage temporarily reduces fever" ], "warnings": [ "Warnings Liver warning This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 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 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. if you have ever had an allergic reaction to this product or any of its ingredients 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 Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not exceed recommended dosage Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion 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 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 In case of overdose, get medical help or contact a Poison Control Center right away (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. if you have ever had an allergic reaction to this product or any of its ingredients" ], "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" ], "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 exceed recommended dosage" ], "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 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 do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets every 4 hours do not take more than 10 caplets in 24 hours children under 12 years ask a doctor" ], "dosage_and_administration_table": [ "
adults and children 12 years and overtake 2 caplets every 4 hoursdo not take more than 10 caplets in 24 hours
children under 12 yearsask a doctor
" ], "storage_and_handling": [ "Other information store between 20-25ºC (68-77ºF) in a dry place retain carton for complete product information and warnings" ], "inactive_ingredient": [ "Inactive ingredients colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide" ], "questions": [ "Questions or comments? 1-844-705-4384" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL HyVee® NDC 42507-320-06 *Compare to the Active Ingredients in Sudafed PE® Sinus Pressure + Pain Non-Drowsy Sinus Pressure + Pain PE Acetaminophen, Phenylephrine HCl Pain Reliever/Fever Reducer Nasal Decongestant For Relief of: • Sinus Pressure & Congestion • Sinus Headache Actual Size 24 CAPLETS image description" ], "set_id": "3e60e32f-3e5f-b775-e063-6294a90a097d", "id": "42b52a08-cab6-75e4-e063-6394a90a4af0", "effective_time": "20251103", "version": "2", "openfda": { "application_number": [ "M012" ], "brand_name": [ "Sinus Pressure and Pain PE" ], "generic_name": [ "ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE" ], "manufacturer_name": [ "HYVEE INC" ], "product_ndc": [ "42507-320" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN", "PHENYLEPHRINE HYDROCHLORIDE" ], "rxcui": [ "1046378" ], "spl_id": [ "42b52a08-cab6-75e4-e063-6394a90a4af0" ], "spl_set_id": [ "3e60e32f-3e5f-b775-e063-6294a90a097d" ], "package_ndc": [ "42507-320-06" ], "is_original_packager": [ true ], "unii": [ "362O9ITL9D", "04JA59TNSJ" ] } } ] }