{"active_ingredient":["Active ingredients (in each caplet) Acetaminophen 250 mg Ibuprofen 125 mg (NSAID**) **nonsteroidal anti-inflammatory drug"],"ask_doctor":["Ask a doctor before use if • you have liver disease • stomach bleeding warning applies to you • you have problems or serious side effects from taking pain relievers • 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 • under a doctor's care for any serious condition • 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 • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist • if you have ever had an allergic reaction to acetaminophen or any other pain reliever • right before or after heart surgery"],"dosage_and_administration":["Directions do not take more than directed adults and children 12 years and over take 2 caplets every 8 hours while symptoms persist children under 12 years ask a doctor do not take more than 6 caplets in 24 hours, unless directed by a doctor"],"dosage_and_administration_table":["
adults and children 12 years and overtake 2 caplets every 8 hours while symptoms persist
children under 12 yearsask a doctor
"],"effective_time":"20250409","id":"32562a4b-8df6-55fb-e063-6394a90ae483","inactive_ingredient":["Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, crospovidone, ferric oxide red, ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, pregelatinized starch, sodium lauryl sulfate, stearic acid and titanium dioxide."],"indications_and_usage":["Uses • temporarily relieves minor aches and pains due to: o backache o muscular aches o minor pain of arthritis o headache o toothache o menstrual cramps"],"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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"openfda":{"application_number":["ANDA216592"],"brand_name":["Acetaminophen and Ibuprofen Back Pain"],"generic_name":["ACETAMINOPHEN AND IBUPROFEN"],"is_original_packager":[true],"manufacturer_name":["Granules Pharmaceuticals Inc."],"nui":["N0000000160","M0001335","N0000175722"],"package_ndc":["70010-213-26","70010-213-31"],"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":["70010-213"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["2387532"],"spl_id":["32562a4b-8df6-55fb-e063-6394a90ae483"],"spl_set_id":["32562aa1-f44b-649e-e063-6394a90a47c8"],"substance_name":["ACETAMINOPHEN","IBUPROFEN"],"unii":["362O9ITL9D","WK2XYI10QM"],"upc":["0370010213265"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL-18's Container Label NDC 70010-213-26 † Compare to the Active Ingredients of Advil ® Dual Action Back Pain Contains 2 Medicines Acetaminophen and Ibuprofen (NSAID) Tablets 250 mg/125 mg Dual Action Pain Reliever Back Pain 8 Hour Relief 18 Caplets* (*capsule-shaped tablets) Ibu-apap-18s-cont-labl","PRINCIPAL DISPLAY PANEL-18's Container Carton Label NDC 70010-213-26 †Compare to the Active Ingredients of Advil® Dual Action Back Pain Contains 2 Medicines Acetaminophen and Ibuprofen (NSAID) Tablets 250 mg/125 mg Dual Action Pain Reliever Back Pain 8 Hour Relief 18 Caplets* (*capsule-shaped tablets) ibu-apap-18s-cont-carton"],"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."],"purpose":["Purposes Pain reliever Pain reliever"],"set_id":"32562aa1-f44b-649e-e063-6394a90a47c8","spl_product_data_elements":["Acetaminophen and Ibuprofen Back Pain Acetaminophen and Ibuprofen HYPROMELLOSE 2910 (6 MPA.S) HYPROMELLOSE 2910 (15 MPA.S) MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE POLYETHYLENE GLYCOL 400 POVIDONE K30 POVIDONE K90 CARNAUBA WAX SILICON DIOXIDE CROSCARMELLOSE SODIUM CROSPOVIDONE FERRIC OXIDE RED FERRIC OXIDE YELLOW HYPROMELLOSE 2910 (3 MPA.S) STARCH, CORN SODIUM LAURYL SULFATE STEARIC ACID TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN IBUPROFEN IBUPROFEN Light yellow to yellow colored capsule shaped, biconvex G;131"],"spl_unclassified_section":["Other information read all warnings and directions before use. Keep carton. store at 20 to 25°C (68 to 77°F) avoid excessive heat above 40°C (104°F)","Questions or comments? call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST."],"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 • redness or swelling is present in the painful area • any new symptoms appear"],"version":"1","warnings":["Warnings Acetaminophen liver damage warning: This product contains acetaminophen. Severe liver damage may occur if you take: with other drugs containing acetaminophen more than 6 caplets in 24 hours, which is the maximum daily amount for this product 3 or more alcoholic drinks every day while using this product Acetaminophen allergy alert: may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If skin reaction occurs, stop use and seek medical help right away. NSAID 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. NSAID 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 • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist • if you have ever had an allergic reaction to acetaminophen or any other pain reliever • right before or after heart surgery Ask a doctor before use if • you have liver disease • stomach bleeding warning applies to you • you have problems or serious side effects from taking pain relievers • 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 a doctor or pharmacist before use if you are • under a doctor's care for any serious condition • 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 10 days • 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 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"when_using":["When using this product • Take with food or milk if stomach upset occurs"]}