{"active_ingredient":["OTC - ACTIVE INGREDIENT SECTION Active ingredients (in each capsule) Purposes Diphenhydramine hydrochloride 25 mg…………………………………...Nighttime sleep-aid Solubilized ibuprofen equal to ibuprofen 200 mg (NSAID)*……………...Pain reliever (present as the free acid and potassium salt) *nonsteroidal anti-inflammatory drug"],"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, or had a stroke. 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 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 capsules at bedtime do not take more than 2 capsules in 24 hours Other information • each capsule contains: potassium 20 mg • 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) • protect from light"],"effective_time":"20250404","id":"1377e093-27d5-4207-b3ee-92a3e9218f69","inactive_ingredient":["Inactive ingredients Anidrisorb, D&C red no. 33, FD&C blue no. 1, gelatin, Hydrolyzed gelatin, medium chain triglyceride. Opacode white ink, Polyethylene glycol 600, potassium hydroxide, purified water. Ingredients of Opacode white ink: shellac glaze in ethanol, titanium dioxide, n-butyl alcohol, lecithin (soya), simethicone and purified water."],"indications_and_usage":["INDICATIONS AND USAGE"],"keep_out_of_reach_of_children":["OTC - KEEP OUT OF REACH OF CHILDREN"],"openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 180 s count container label 180 s count container label 20 s count container label 20 s count container label 20 s count carton label 20 s count carton label 180 s carton label 180 s carton label 180 s count container label 20 s count container label 20 s count carton label 180 s carton label"],"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 . In case of overdose, get medical help or contact a Poison Control Center right away."],"purpose":["OTC - PURPOSE SECTION"],"questions":["Questions or comments? Call at 1877 244 9825 Manufactured by: Strides Pharma Science Limited Bengaluru - 562106, India Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816 Revised: 01/2022"],"set_id":"10d52858-a55f-4053-aa77-da660556a2ad","spl_product_data_elements":["IBUPROFEN AND DIPHENHYDRAMINE HCL IBUPROFEN AND DIPHENHYDRAMINE HCL DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE IBUPROFEN IBUPROFEN D&C RED NO. 33 FD&C BLUE NO. 1 GELATIN MEDIUM-CHAIN TRIGLYCERIDES POTASSIUM HYDROXIDE WATER SORBITAN SORBITOL POLYETHYLENE GLYCOL 600 Bluish purple color 1007"],"spl_unclassified_section":["Drug Facts"],"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 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"],"use_in_specific_populations":["Uses for relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep"],"version":"10","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."],"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"]}