{"active_ingredient":["Active ingredient & Purpose Active ingredient (in each 5 mL) Purpose Ibuprofen 100 mg (NSAID)*....................................................... Pain reliever / fever reducer *nonsteroidal anti-inflammatory"],"active_ingredient_table":["
Active ingredient (in each 5 mL)Purpose
Ibuprofen 100 mg (NSAID)*.......................................................Pain reliever / fever reducer
*nonsteroidal anti-inflammatory
"],"ask_doctor":["Ask a doctor before use if stomach bleeding warning applies to your child child has a history of stomach problems, such as heartburn child has problems or serious side effects from taking pain relievers or fever reducers child has not been drinking fluids child has lost a lot of fluid due to vomiting or diarrhea child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or had a stroke child has asthma child is taking a diuretic"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if the child is under a doctor's care for any serious condition taking any other drug"],"do_not_use":["Do not use if the child has ever had an allergic reaction to Ibuprofen or any other pain reliever/fever reducer right before or after heart surgery"],"dosage_and_administration":["Directions this product does not contain directions or complete warnings for adult use do not give more than directed shake well before using mL = milliliter find right dose on chart. If possible, use weight to dose; otherwise use age. use only enclosed dosing cup. Do not use any other dosing device. if needed, repeat dose every 6-8 hours not use more than 4 times a day replace original bottle cap to maintain child resistance Weight (lb) Age (yr) Dose (mL)* under 24 under 2 years ask a doctor 24-35 lbs 2-3 years 5 mL 36-47 lbs 4-5 years 7.5 48-59 6-8 years 10 mL 60-71 lbs 9-10 years 12.5 mL 72-95 lbs 11 years 15 mL *or as directed by a doctor"],"dosage_and_administration_table":["
Weight (lb)Age (yr)Dose (mL)*
under 24under 2 yearsask a doctor
24-35 lbs2-3 years5 mL
36-47 lbs4-5 years7.5
48-596-8 years10 mL
60-71 lbs9-10 years12.5 mL
72-95 lbs11 years15 mL
"],"effective_time":"20200806","id":"ac3c264f-da36-a474-e053-2a95a90abdad","inactive_ingredient":["Inactive ingredients acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, D&C Yellow #10, FD&C Red #40, flavors, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium, benzoate, sucrose, and xanthan gum"],"indications_and_usage":["Uses temporarily: relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache 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 right away. (1-800-222-1222)"],"openfda":{"application_number":["ANDA210602"],"brand_name":["Dolex Children"],"generic_name":["IBUPROFEN"],"is_original_packager":[true],"manufacturer_name":["Pharmadel LLC"],"nui":["N0000000160","M0001335","N0000175722"],"package_ndc":["55758-304-04"],"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":["55758-304"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"spl_id":["ac3c264f-da36-a474-e053-2a95a90abdad"],"spl_set_id":["ac3c264f-da37-a474-e053-2a95a90abdad"],"substance_name":["IBUPROFEN"],"unii":["WK2XYI10QM"]},"package_label_principal_display_panel":["PACKAGE PRINCIPAL DISPLAY PANEL DOLEX CHILDREN"],"purpose":["Active ingredient (in each 5 mL) Purpose Ibuprofen 100 mg (NSAID)*....................................................... Pain reliever / fever reducer *nonsteroidal anti-inflammatory"],"purpose_table":["
Active ingredient (in each 5 mL)Purpose
Ibuprofen 100 mg (NSAID)*.......................................................Pain reliever / fever reducer
*nonsteroidal anti-inflammatory
"],"questions":["Questions or comments? Call 732-314-4550 from 9 AM to 5 PM EST, Monday – Friday"],"set_id":"ac3c264f-da37-a474-e053-2a95a90abdad","spl_product_data_elements":["Dolex Children Ibuprofen SUCROSE ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID D&C YELLOW NO. 10 CARBOXYMETHYLCELLULOSE SODIUM XANTHAN GUM CELLULOSE, MICROCRYSTALLINE WATER POLYSORBATE 80 PROPYLENE GLYCOL SODIUM BENZOATE IBUPROFEN IBUPROFEN GLYCERIN FD&C RED NO. 40"],"spl_unclassified_section":["Drug Facts Drug Facts"],"stop_use":["Stop use and ask a doctor if child experiences any of the following signs of stomach bleeding: feels faint vomits blood has bloody or black stools has stomach pain that does not get better child has symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling the child does not get any relief within first day (24 hours) of treatment fever or pain gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear"],"storage_and_handling":["Other information each 5 mL contains : sodium 2 mg store between 20-25°C (68-77°F) do not use if carton is opened or printed bottle neckband is broken or missing see bottom panel for lot number and expiration date"],"version":"1","warnings":["Warnings Allergy Alert: 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 your child: has had stomach ulcers or bleeding problems takes a blood thinning (anticoagulant) or steroid drug takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) takes more or for a longer time than directed Heart attack and stroke warning: NSAIDs, exceptaspirin, 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. Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor. Do not use if the child has ever had an allergic reaction to Ibuprofen or any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if stomach bleeding warning applies to your child child has a history of stomach problems, such as heartburn child has problems or serious side effects from taking pain relievers or fever reducers child has not been drinking fluids child has lost a lot of fluid due to vomiting or diarrhea child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or had a stroke child has asthma child is taking a diuretic Ask a doctor or pharmacist before use if the child is under a doctor's care for any serious condition taking any other drug When using this product take with food or milk if stomach upset occurs Stop use and ask a doctor if child experiences any of the following signs of stomach bleeding: feels faint vomits blood has bloody or black stools has stomach pain that does not get better child has symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling the child does not get any relief within first day (24 hours) of treatment fever or pain gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear 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 take with food or milk if stomach upset occurs"]}