{"active_ingredient":["Active ingredients (in each caplet) Diphenhydramine citrate 38 mg Ibuprofen 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug Purposes Nighttime sleep-aid Pain reliever"],"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, or asthma • you are taking a diuretic • you have a breathing problem such as emphysema or chronic bronchitis • you have glaucoma • 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 • under a doctor’s care for any continuing medical illness • taking any other antihistamines • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin • taking any other drug"],"do_not_use":["Do not use • if you have ever had an allergic reaction to any other pain reliever/fever reducer • unless you have time for a full night’s sleep • in children under 12 years of age • right before or after heart surgery • 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 children 12 years and over: take 2 caplets at bedtime • do not take more than 2 caplets in 24 hours"],"effective_time":"20260408","id":"4efb3fed-e69e-91c7-e063-6294a90aafdd","inactive_ingredient":["Inactive ingredients calcium stearate, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue no. 2 aluminum lake, glyceryl behenate, hypromellose, lactose monohydrate, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyethylene glycol, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide"],"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 the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["NDA021394"],"brand_name":["Advil PM"],"generic_name":["DIPHENHYDRAMINE CITRATE, IBUPROFEN"],"manufacturer_name":["Navajo Manufacturing Company Inc."],"nui":["N0000000160","M0001335","N0000175722"],"original_packager_product_ndc":["0573-0164"],"package_ndc":["67751-147-01","67751-147-02","67751-147-06"],"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":["67751-147"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["895664"],"spl_id":["4efb3fed-e69e-91c7-e063-6294a90aafdd"],"spl_set_id":["a3c30dd2-75f3-4f8b-88d7-4a63dea5bad7"],"substance_name":["DIPHENHYDRAMINE CITRATE","IBUPROFEN"],"unii":["4OD433S209","WK2XYI10QM"]},"package_label_principal_display_panel":["Package Labeling: Advil PM"],"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":["Purposes Nighttime sleep-aid Pain reliever"],"questions":["Questions or comments? Call toll free 1-800-88-ADVIL"],"set_id":"a3c30dd2-75f3-4f8b-88d7-4a63dea5bad7","spl_product_data_elements":["Advil PM DIPHENHYDRAMINE CITRATE, IBUPROFEN CALCIUM STEARATE CARNAUBA WAX SILICON DIOXIDE STARCH, CORN CROSCARMELLOSE SODIUM FD&C BLUE NO. 2 ALUMINUM OXIDE GLYCERYL DIBEHENATE HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MICROCRYSTALLINE CELLULOSE POLYDEXTROSE POLYETHYLENE GLYCOL, UNSPECIFIED SODIUM LAURYL SULFATE STEARIC ACID TITANIUM DIOXIDE DIPHENHYDRAMINE CITRATE DIPHENHYDRAMINE IBUPROFEN IBUPROFEN Advil;PM"],"spl_unclassified_section":["Drug Facts","Other information • read all warnings and directions before use. Keep carton. • store at 20-25°C (68-77°F) • avoid excessive heat above 40°C (104°F)"],"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 • pain gets worse or lasts 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"],"version":"3","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 • rash • skin reddening • 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 Do not use • if you have ever had an allergic reaction to any other pain reliever/fever reducer • unless you have time for a full night’s sleep • in children under 12 years of age • right before or after heart surgery • with any other product containing diphenhydramine, even one used on skin • if you have sleeplessness without pain 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, or asthma • you are taking a diuretic • you have a breathing problem such as emphysema or chronic bronchitis • you have glaucoma • 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 • under a doctor’s care for any continuing medical illness • taking any other antihistamines • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin • taking any other drug 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 • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed 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 • pain gets worse or lasts 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 the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"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 • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed"]}