{ "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": 2 } }, "results": [ { "spl_product_data_elements": [ "Sudafed PE Head Congestion Plus Pain Ibuprofen and Phenylephrine Hydrochloride MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED STEARIC ACID TALC TITANIUM DIOXIDE IBUPROFEN IBUPROFEN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE SILICON DIOXIDE CROSCARMELLOSE SODIUM LACTOSE MONOHYDRATE SUPE" ], "spl_unclassified_section": [ "Drug Facts" ], "active_ingredient": [ "Active ingredients (in each caplet) Purposes Ibuprofen 200 mg (NSAID) nonsteroidal anti-inflammatory drug Pain reliever/fever reducer Phenylephrine HCl 10 mg Nasal decongestant" ], "active_ingredient_table": [ "
Active ingredients (in each caplet)Purposes
Ibuprofen 200 mg (NSAID) nonsteroidal anti-inflammatory drugPain reliever/fever reducer
Phenylephrine HCl 10 mgNasal decongestant
" ], "purpose": [ "Active ingredients (in each caplet) Purposes Ibuprofen 200 mg (NSAID) nonsteroidal anti-inflammatory drug Pain reliever/fever reducer Phenylephrine HCl 10 mg Nasal decongestant" ], "purpose_table": [ "
Active ingredients (in each caplet)Purposes
Ibuprofen 200 mg (NSAID) nonsteroidal anti-inflammatory drugPain reliever/fever reducer
Phenylephrine HCl 10 mgNasal decongestant
" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms associated with the common cold or flu: headache fever sinus pressure nasal congestion minor body aches and pains reduces swelling of the nasal passages temporarily restores freer breathing through the nose" ], "warnings": [ "Warnings Allergy alert Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Heart attack and stroke warning NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. Do not use in children under 12 years of age because this product contains too much medication for children under this age if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery 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 stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland, or had a stroke you are taking a diuretic Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking any other product that contains phenylephrine or any other nasal decongestant taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug When using this product take with food or milk if stomach upset occurs Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling pain gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days nasal congestion lasts for more than 7 days symptoms continue or get worse redness or swelling is present in the painful area you get nervous, dizzy, or sleepless any new symptoms appear If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. 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 in children under 12 years of age because this product contains too much medication for children under this age if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery 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 stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland, or had a stroke you are taking a diuretic" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking any other product that contains phenylephrine or any other nasal decongestant taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug" ], "when_using": [ "When using this product take with food or milk if stomach upset occurs" ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling pain gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days nasal congestion lasts for more than 7 days symptoms continue or get worse redness or swelling is present in the painful area you get nervous, dizzy, or sleepless any new symptoms appear" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "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 directed adults and children 12 years of age and over: take 1 caplet every 4 hours while symptoms persist do not use more than 6 caplets in any 24-hour period unless directed by a doctor children under 12 years of age: do not use because this product contains too much medication for children under this age" ], "storage_and_handling": [ "Other information store between 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F). read all warnings and directions before use. Keep carton. do not use if blister unit is torn or broken" ], "inactive_ingredient": [ "Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, stearic acid, talc, titanium dioxide" ], "questions": [ "Questions or comments? call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 50580-436-01 SUDAFED PE® HEAD CONGESTION + PAIN Ibuprofen 200 mg, Phenylephrine Hydrochloride 10 mg Tablets Pain Reliever/Fever Reducer (NSAID), Nasal Decongestant • NASAL CONGESTION • HEADACHE • SINUS PRESSURE • FEVER • NASAL SWELLING • BODY ACHES ONE CAPLET DOSE! actual size 20 COATED CAPLETS** **CAPSULE-SHAPED TABLETS NON-DROWSY Sudafed_2jpg" ], "set_id": "76513fb2-7323-4f1f-8a10-92f8f603cf97", "id": "2ffbcc44-0ef3-b149-e063-6394a90ae7f5", "effective_time": "20250310", "version": "5", "openfda": { "application_number": [ "ANDA203200" ], "brand_name": [ "Sudafed PE Head Congestion Plus Pain" ], "generic_name": [ "IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE" ], "manufacturer_name": [ "Kenvue Brands LLC" ], "product_ndc": [ "50580-436" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "IBUPROFEN", "PHENYLEPHRINE HYDROCHLORIDE" ], "rxcui": [ "1369775" ], "spl_id": [ "2ffbcc44-0ef3-b149-e063-6394a90ae7f5" ], "spl_set_id": [ "76513fb2-7323-4f1f-8a10-92f8f603cf97" ], "package_ndc": [ "50580-436-01" ], "is_original_packager": [ true ], "upc": [ "0300450551207" ], "nui": [ "N0000000160", "M0001335", "N0000175722" ], "pharm_class_moa": [ "Cyclooxygenase Inhibitors [MoA]" ], "pharm_class_cs": [ "Anti-Inflammatory Agents, Non-Steroidal [CS]" ], "pharm_class_epc": [ "Nonsteroidal Anti-inflammatory Drug [EPC]" ], "unii": [ "WK2XYI10QM", "04JA59TNSJ" ] } } ] }