{"active_ingredient":["Active ingredient (in each 5 mL cup) Ibuprofen 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, 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. if needed repeat dose every 6–8 hours do not use more than 4 times a day Dosing Chart Weight (lb) Age (yr) Dose (mL) or as directed by a doctor under 24 under 2 years ask a doctor 24-35 lbs 2-3 years 5 mL (1 unit dose cup) 36-47 lbs 4-5 years 7.5 mL (1.5 unit dose cups) 48-59 lbs 6-8 years 10 mL (2 unit dose cups) 60-71 lbs 9-10 years 12.5 mL (2.5 unit dose cups) 72-95 lbs 11 years 15 mL (3 unit dose cups)"],"dosage_and_administration_table":["
Dosing Chart
Weight (lb)Age (yr)Dose (mL)or as directed by a doctor
under 24under 2 yearsask a doctor
24-35 lbs2-3 years5 mL (1 unit dose cup)
36-47 lbs4-5 years7.5 mL (1.5 unit dose cups)
48-59 lbs6-8 years10 mL (2 unit dose cups)
60-71 lbs9-10 years12.5 mL (2.5 unit dose cups)
72-95 lbs11 years15 mL (3 unit dose cups)
"],"effective_time":"20231205","id":"0bcab4c1-507c-4dfe-e063-6294a90af06d","inactive_ingredient":["Inactive ingredients: Acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, 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":["Childrens Ibuprofen"],"generic_name":["IBUPROFEN"],"manufacturer_name":["American Health Packaging"],"nui":["N0000000160","M0001335","N0000175722"],"original_packager_product_ndc":["76281-128"],"package_ndc":["60687-743-40","60687-743-46","60687-743-17"],"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":["60687-743"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["197803"],"spl_id":["0bcab4c1-507c-4dfe-e063-6294a90af06d"],"spl_set_id":["bc69d88b-d9af-4010-8e8f-e761a9e295a9"],"substance_name":["IBUPROFEN"],"unii":["WK2XYI10QM"]},"package_label_principal_display_panel":["Principal Display Panel – Tray Label Case NDC 60687-743-17/Cup NDC 60687-743-40 Children’s Ibuprofen Oral Suspension, USP (NSAID) 100 mg per 5 mL Pain Reliever/Fever Reducer Berry Flavored/Dye Free/Alcohol Free SHAKE WELL USUAL DOSAGE: See attached Drug Facts Store at 20° to 25°C (68° to 77°F) For Institutional Use Only. T1022C050723 R07/23 100 mg per 5 mL Childrens Ibuprofen Oral Suspension Tray Labell","Principal Display Panel – Cup - 100 mg / 5 mL NDC 60687- 743 -40 Children's Ibuprofen Oral Suspension, USP (NSAID) Pain Reliever/Fever Reducer 100 mg per 5 ml Berry Flavored/Dye Free/ Alcohol Free Delivers 5 mL SHAKE WELL See package Drug Facts insert for full prescribing information and storage. For Institutional Use Only. American Health Packaging Columbus, OH 43217 A1022C05/1023 100 mg per 5 mL Childrens Ibuprofen Oral Suspension Cup Lid"],"purpose":["Purpose Pain reliever/fever reducer"],"questions":["Questions or comments? Call 1-800-845-8210."],"set_id":"bc69d88b-d9af-4010-8e8f-e761a9e295a9","spl_product_data_elements":["Childrens Ibuprofen Ibuprofen ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED GLYCERIN MICROCRYSTALLINE CELLULOSE POLYSORBATE 80 PROPYLENE GLYCOL WATER SODIUM BENZOATE SUCROSE XANTHAN GUM IBUPROFEN IBUPROFEN"],"spl_unclassified_section":["Important: Read all product information before using. Keep this insert for important information. This product is intended for use in children.","Drug Facts","Other information each 5 mL contains: sodium 2 mg store between 20° to 25°C (68° to 77°F) Children’s Ibuprofen Oral Suspension is a clear, berry flavored suspension supplied in the following oral dosage forms: 5 mL unit dose cups: 100 cups (10 x 10) NDC 60687‐743‐17","*All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Children's Motrin ® Dye-Free Berry Flavor. DO NOT USE IF SEAL IS BROKEN. Distributed by: American Health Packaging Columbus, OH 43217 R07/23"],"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"],"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)"],"when_using":["When using this product take with food or milk if stomach upset occurs"]}