{"active_ingredient":["ACTIVE INGREDIENT (in each tablet) Ibuprofen USP, 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug"],"ask_doctor":["ASK DOCTOR before use if you have problems or serious side effects from taking pain relievers or fever reducers the stomach bleeding warning applies to you 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"],"ask_doctor_or_pharmacist":["ASK A DOCTOR OR PHARMACIST before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor’s care for any serious condition taking any other drug"],"do_not_use":["DO NOT USE if you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer right before or after heart surgery"],"dosage_and_administration":["DIRECTIONS do not take more than directed the smallest effective dose should be used Adults and children 12 years of age and over: ■ Take 1 tablet every 4 to 6 hours while symptoms persist ■ If pain or fever does not respond to 1 tablet, 2 tablets may be used ■ Do not exceed 6 tablets in 24 hours, unless directed by a doctor Children under 12 years of age: ■ Ask a doctor"],"effective_time":"20181107","id":"77cf0092-7436-14ba-e053-2991aa0ac112","inactive_ingredient":["INACTIVE INGREDIENTS (White) Carnauba Wax, Croscarmellose Sodium, Hypromellose, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Povidone, Pregelatinized Starch, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid, and Titanium Dioxide. (Orange) Croscarmellose Sodium, FD&C Yellow #6 Lake, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Pregelatinized Starch, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid, Talc and Titanium Dioxide. (Brown) Croscarmellose Sodium, Hydroxypropylcellulose, Hypromellose, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Pregelatinized Starch, Red Iron Oxide, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid, and Titanium Dioxide."],"indications_and_usage":["USES Temporarily relieves minor aches and pains due to: headache muscular ache minor pain of arthritis toothache backache the common cold menstrual cramps temporarily reduces fever"],"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 (1-800-222-1222) right away."],"openfda":{"application_number":["ANDA071265"],"brand_name":["ibuprofen"],"generic_name":["IBUPROFEN"],"is_original_packager":[true],"manufacturer_name":["Contract Pharmacal Corp."],"nui":["N0000000160","M0001335","N0000175722"],"package_ndc":["10267-3852-2","10267-3846-2","10267-3909-2"],"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":["10267-3846","10267-3852","10267-3909"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["310965"],"spl_id":["77cf0092-7436-14ba-e053-2991aa0ac112"],"spl_set_id":["237bcb87-64a0-415b-bd53-e9d3b8bf33b6"],"substance_name":["IBUPROFEN"],"unii":["WK2XYI10QM"],"upc":["0310267390920","0310267385223"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL See New Warnings CONTRACT PHARMACAL CORP NDC 10267-3909-2 **Compares to the active ingredient in Motrin ® IB GLUTEN FREE Ibuprofen Tablets, USP 200 mg Pain Reliever/Fever Reducer (NSAID) 250 Coated Tablets DYE-FREE NOT ACTUAL SIZE See New Warnings CONTRACT PHARMACAL CORP NDC 10267-3846-2 **Compares to the active ingredient in Motrin ® IB GLUTEN FREE Ibuprofen Tablets, USP 200 mg Pain Reliever/Fever Reducer (NSAID) 250 Coated Tablets NOT ACTUAL SIZE See New Warnings CONTRACT PHARMACAL CORP NDC 10267-3852-2 **Compares to the active ingredient in Motrin ® IB GLUTEN FREE Ibuprofen Tablets, USP 200 mg Pain Reliever/Fever Reducer (NSAID) 250 Coated Tablets NOT ACTUAL SIZE Ibuprofen white label 3909 Ibuprofen Orange label 3846 Ibuprofen Brown label"],"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 Pain reliever/fever reducer"],"questions":["QUESTIONS or COMMENTS? Call 1-800-231-4670 : weekdays 9:00 AM to 5:00 PM EST"],"set_id":"237bcb87-64a0-415b-bd53-e9d3b8bf33b6","spl_product_data_elements":["ibuprofen ibuprofen CROSCARMELLOSE SODIUM STARCH, CORN CELLULOSE, MICROCRYSTALLINE STEARIC ACID SODIUM STARCH GLYCOLATE TYPE A CORN POVIDONE K30 SILICON DIOXIDE FERRIC OXIDE RED TITANIUM DIOXIDE POLYETHYLENE GLYCOL 400 HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSES IBUPROFEN IBUPROFEN C1 convex ibuprofen ibuprofen CROSCARMELLOSE SODIUM STARCH, CORN CELLULOSE, MICROCRYSTALLINE STEARIC ACID SODIUM STARCH GLYCOLATE TYPE A CORN POVIDONE K30 SILICON DIOXIDE POLYVINYL ALCOHOL POLYETHYLENE GLYCOL 400 FD&C YELLOW NO. 6 TALC TITANIUM DIOXIDE IBUPROFEN IBUPROFEN C1 convex ibuprofen ibuprofen CROSCARMELLOSE SODIUM STARCH, CORN CELLULOSE, MICROCRYSTALLINE STEARIC ACID SODIUM STARCH GLYCOLATE TYPE A CORN POVIDONE K30 SILICON DIOXIDE TITANIUM DIOXIDE HYDROXYPROPYL CELLULOSE, UNSPECIFIED POLYETHYLENE GLYCOL 400 POLYSORBATE 80 CARNAUBA WAX IBUPROFEN IBUPROFEN C1 convex"],"spl_unclassified_section":["Important: Read all product information before using. DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. Drug Facts","Other information store between 20˚ to 25˚C (68˚to 77˚F) avoid excessive heat above 40˚C (104˚F)","**This product is not manufactured or distributed by McNeil, owner of the registered trademark Motrin®IB Manufactured by: Contract Pharmacal Corp. 135 Adams Avenue Hauppauge, NY 11788 USA www.cpc.com XXXXX-10-18 Barcode Peel here for more information"],"stop_use":["STOP USE and ask a doctor if you experience and 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 fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear"],"version":"13","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 non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for longer time than directed Heart attack and stroke warning : NSAIDs, except aspirin, increases 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 take with food or milk if stomach upset occurs"]}