{"active_ingredient":["Active ingredient (in each 5 mL) Ibuprofen USP 100 mg (NSAID)* *nonsteroidal anti-inflammatory drug"],"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 to 8 hours • do not use more than 4 times a day • replace original bottle cap to maintain child resistance • wash dosage cup after each use Dosing Chart Weight (lb) Age (year) Dose (mL)* under 24 lbs under 2 years ask a doctor 24-35 lbs 2-3 years 5 mL 36-47 lbs 4-5 years 7.5 mL 48-59 lbs 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":["
Dosing Chart
Weight (lb)Age (year) Dose (mL)*
under 24 lbsunder 2 years ask a doctor
24-35 lbs 2-3 years5 mL
36-47 lbs 4-5 years 7.5 mL
48-59 lbs 6-8 years10 mL
60-71 lbs 9-10 years12.5 mL
72-95 lbs 11 years15 mL
"],"effective_time":"20240130","id":"1fb62f8c-355b-4760-90c8-a32f8b7dfde8","inactive_ingredient":["Inactive ingredients Acesulfame potassium, citric acid anhydrous, D&C yellow No. 10, FD&C red No. 40, glycerin, hypromellose, N&A flavor for cherry blast, N&A strawberry flavor wild, polysorbate 80, pregelatinized starch (potato), 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":["ANDA209179"],"brand_name":["Childrens FLANAX ORAL"],"generic_name":["IBUPROFEN"],"is_original_packager":[true],"manufacturer_name":["Belmora LLC"],"nui":["N0000000160","M0001335","N0000175722"],"package_ndc":["27854-777-99"],"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":["27854-777"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["197803"],"spl_id":["1fb62f8c-355b-4760-90c8-a32f8b7dfde8"],"spl_set_id":["9b9318cb-3bc7-40ca-bf8a-7495d93869b3"],"substance_name":["IBUPROFEN"],"unii":["WK2XYI10QM"]},"package_label_principal_display_panel":["Packaging FLANAX-777"],"purpose":["Purpose Pain reliever/ fever reducer"],"questions":["Questions or comments? 1-888-779-2877 9AM-5PM EST Mon-Fri."],"set_id":"9b9318cb-3bc7-40ca-bf8a-7495d93869b3","spl_product_data_elements":["Childrens FLANAX ORAL Ibuprofen IBUPROFEN IBUPROFEN ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID D&C YELLOW NO. 10 FD&C RED NO. 40 GLYCERIN HYPROMELLOSE 2208 (4000 MPA.S) CHERRY STRAWBERRY POLYSORBATE 80 STARCH, POTATO PROPYLENE GLYCOL WATER SODIUM BENZOATE SUCROSE XANTHAN GUM"],"spl_unclassified_section":["Drug Facts","LASTS UP TO 8 HOURS for kids Berry Flavor Alcohol Free Important: Read all product information before using. Keep this box for important information. This product is intended for use in children. KEEP IN OUTER CARTON UNTIL CONTENTS USED Distributed by: Belmora LLC, 3033 Wilson Blvd., Suite 700, Arlington, VA 22201 Made in India Code: AP/DRUGS/04/2016"],"storage_and_handling":["Other information • each 5 mL contains: sodium 2 mg • store between 20 to 25°C (68 to 77°F) • do not use if carton is opened or seal under cap opening is broken or missing • see bottom panel for lot number and expiration date"],"version":"1","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 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, 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. 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)"]}