{"active_ingredient":["ACTIVE INGREDIENT (in each 5 mL) Ibuprofen, USP 100 mg (NSAID)* *nonsteroidal anti-inflammatory drug"],"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, or 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 do not use more than 4 times a day replace original bottle cap to maintain child resistance Dosing Chart 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 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":["<table cellspacing=\"0\" cellpadding=\"0\" border=\"0\"><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" valign=\"middle\"><content styleCode=\"bold\">Weight (lb) </content></td><td styleCode=\"Rrule\" valign=\"middle\"><content styleCode=\"bold\">Age (yr) </content></td><td styleCode=\"Rrule\" valign=\"middle\"><content styleCode=\"bold\">Dose (mL)*</content> </td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" valign=\"middle\"> under 24</td><td styleCode=\"Rrule\" valign=\"middle\"> under 2 years</td><td styleCode=\"Rrule\" valign=\"middle\"> ask a doctor</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" valign=\"middle\"> 24-35 lbs</td><td styleCode=\"Rrule\" valign=\"middle\"> 2-3 years</td><td styleCode=\"Rrule\" valign=\"middle\"> 5 mL</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" valign=\"middle\"> 36-47 lbs</td><td styleCode=\"Rrule\" valign=\"middle\"> 4-5 years</td><td styleCode=\"Rrule\" valign=\"middle\"> 7.5 mL</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" valign=\"middle\"> 48-59 lbs</td><td styleCode=\"Rrule\" valign=\"middle\"> 6-8 years</td><td styleCode=\"Rrule\" valign=\"middle\"> 10 mL</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" valign=\"middle\"> 60-71 lbs</td><td styleCode=\"Rrule\" valign=\"middle\"> 9-10 years</td><td styleCode=\"Rrule\" valign=\"middle\"> 12.5 mL</td></tr><tr><td styleCode=\"Lrule Rrule\" valign=\"middle\"> 72-95 lbs</td><td styleCode=\"Rrule\" valign=\"middle\"> 11 years</td><td styleCode=\"Rrule\" valign=\"middle\"> 15 mL</td></tr></tbody></table>"],"effective_time":"20251203","id":"f61d1d25-e295-4635-b174-1020ff44c234","inactive_ingredient":["INACTIVE INGREDIENTS anhydrous citric acid, D&C yellow no. 10, FD&C red no. 40, flavor, glycerin, polysorbate 80, pregelatinized starch, purified water, sodium benzoate, sucrose, xanthan gum."],"indications_and_usage":["USE(S) 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":["ANDA210149"],"brand_name":["Childrens Ibuprofen"],"generic_name":["IBUPROFEN"],"is_original_packager":[true],"manufacturer_name":["Family Dollar Services, Inc."],"nui":["N0000000160","M0001335","N0000175722"],"package_ndc":["55319-114-03"],"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":["55319-114"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["197803"],"spl_id":["f61d1d25-e295-4635-b174-1020ff44c234"],"spl_set_id":["137a0290-822a-842d-e063-6294a90a5c18"],"substance_name":["IBUPROFEN"],"unii":["WK2XYI10QM"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL FAMILY Wellness COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S MOTRIN ®* Children's IBUPROFEN ORAL SUSPENSION USP 100 mg per 5 mL Pain Reliever/Fever Reducer (NSAID) Alcohol Free Mixed Berry Flavor 4 FL OZ (120 mL) 634-fw-new-label.jpg 634-fw-new-carton.jpg"],"purpose":["PURPOSE Pain reliever/fever reducer"],"questions":["QUESTIONS OR COMMENTS? call 1-609-860-2600 (Monday-Friday 8 am - 4 pm)"],"set_id":"137a0290-822a-842d-e063-6294a90a5c18","spl_product_data_elements":["Childrens Ibuprofen Ibuprofen IBUPROFEN IBUPROFEN ANHYDROUS CITRIC ACID D&C YELLOW NO. 10 FD&C RED NO. 40 GLYCERIN POLYSORBATE 80 STARCH, PREGELATINIZED CORN WATER SODIUM BENZOATE SUCROSE XANTHAN GUM Mixed Berry"],"stop_use":["STOP USE AND ASK 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 the 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 o C (68-77 o F) do not use if carton is opened or if printed inner seal imprinted with \"SEALED for YOUR PROTECTION\" is broken or missing."],"version":"3","warnings":["WARNINGS Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives asthma (wheezing) skin reddening facial swelling shock 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."],"when_using":["WHEN USING THIS PRODUCT take with food or milk if stomach upset occurs"]}