{"active_ingredient":["Active ingredient (in each capsule) Diphenhydramine hydrochloride 25 mg Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)* (present as the free acid and potassium salt) *non-steroidal anti-inflammatory drug"],"ask_doctor":["Ask a doctor before use if the stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have glaucoma you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma or had a stroke you are taking a diuretic you have problems or serious side effects from taking pain relievers or fever reducers you have a breathing problem such as emphysema or chronic bronchitis you have trouble urinating due to an enlarged prostate gland"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers, or any other sleep-aid taking any other drug taking any other antihistamines taking aspirin for heart attack or stroke, because ibuprofen may decease this benefit of aspirin under a doctor's care for any continuing medical illness"],"do_not_use":["Do not use in children under 12 years of age if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery unless you have time for a full night’s sleep with any other product containing diphenhydramine, even one used on skin if you have sleeplessness without pain"],"dosage_and_administration":["Directions do not take more than directed adults and childlren 12 years and over: take 2 capsules at bedtime do not take more than 2 capsules in 24 hours"],"effective_time":"20260519","id":"297ebb27-968b-44e8-9318-511c73adacfc","inactive_ingredient":["Inactive ingredients D&C red #33, FD&C blue #1, gelatin, medium chain triglycerides, polyethylene glycol 600, potassium hydroxide, purified water, sorbitan, sorbitol"],"indications_and_usage":["Uses for relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep"],"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)."],"openfda":{"application_number":["ANDA200888"],"brand_name":["Ibuprofen PM"],"generic_name":["IBUPROFEN, DIPHENHYDRAMINE HCL"],"is_original_packager":[true],"manufacturer_name":["TOP CARE (Topco Associates LLC)"],"nui":["N0000000160","M0001335","N0000175722"],"package_ndc":["36800-756-40"],"pharm_class_cs":["Anti-Inflammatory Agents, Non-Steroidal [CS]"],"pharm_class_epc":["Nonsteroidal Anti-inflammatory Drug [EPC]"],"pharm_class_moa":["Cyclooxygenase Inhibitors [MoA]"],"product_ndc":["36800-756"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["901814"],"spl_id":["297ebb27-968b-44e8-9318-511c73adacfc"],"spl_set_id":["7af82ca5-ea36-4b72-88b8-0fe68348d269"],"substance_name":["IBUPROFEN","DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["WK2XYI10QM","TC2D6JAD40"],"upc":["0036800207691"]},"package_label_principal_display_panel":["Principal Display Panel COMPARE TO ADVIL®PM LIQUI-GELS® ACTIVE INGREDIENTS† NIGHTTIME Ibuprofen PM Capsules PAIN RELIEVER (NSAID) • NIGHTTIME SLEEP-AID IBUPROFEN & DIPHENHYDRAMINE HCI 200 mg/25mg SOFTGELS ** **Liquid-Filled Capsules †This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Advil® PM Liqui-Gels®. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 ©TOPCO PLVA0318 topcare@topco.com www.topcarebrand.com","Product Packaging TOPCARE Ibuprofen 200 mg Softgels Diphenhydramine HCI 25 mg, Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)* (present as the free acid and potassium salt) *nonsteroidal anti-inflammatory drug"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery."],"purpose":["Purpose Nighttime sleep-aid Pain Reliever"],"questions":["Questions or comments? Call toll free 1-888-423-0139"],"set_id":"7af82ca5-ea36-4b72-88b8-0fe68348d269","spl_product_data_elements":["Ibuprofen PM IBUPROFEN, DIPHENHYDRAMINE HCL IBUPROFEN IBUPROFEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE FD&C BLUE NO. 1 D&C RED NO. 33 GELATIN POLYETHYLENE GLYCOL 600 POTASSIUM HYDROXIDE WATER SORBITAN SORBITOL MEDIUM-CHAIN TRIGLYCERIDES 1007"],"stop_use":["Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain trouble breathing leg swelling slurred speech weakness in one part or side of body pain gets worse or last more than 10 days sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness redness or swelling is present in the painful area any new symptoms appear"],"storage_and_handling":["Other information each capsule contains: potassium 20 mg store at 20º to 25ºC (68º to 77ºF) avoid excessive heat above 40°C (104°F) protect from light swallow whole: do not crush, chew, or dissolve read all warnings and directions before use. Keep carton."],"version":"4","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: have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug are age 60 or older take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] take more or for a longer time than directed have 3 or more alcoholic drinks every day while using this product 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 if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery unless you have time for a full night’s sleep with any other product containing diphenhydramine, even one used on skin if you have sleeplessness without pain Ask a doctor before use if the stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have glaucoma you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma or had a stroke you are taking a diuretic you have problems or serious side effects from taking pain relievers or fever reducers you have a breathing problem such as emphysema or chronic bronchitis you have trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers, or any other sleep-aid taking any other drug taking any other antihistamines taking aspirin for heart attack or stroke, because ibuprofen may decease this benefit of aspirin under a doctor's care for any continuing medical illness When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery 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 have bloody or black stools vomit blood have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain trouble breathing leg swelling slurred speech weakness in one part or side of body pain gets worse or last more than 10 days sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of 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)."],"when_using":["When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery take with food or milk if stomach upset occurs"]}