{"active_ingredient":["Drug Facts Active ingredient (in each 1.25 mL) Ibuprofen USP 50 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 find right dose on chart below. If possible, use weight to dose; otherwise use age. mL = milliliter measure with the dosing device provided. Do not use with any other device. dispense liquid slowly into the child's mouth, toward the inner cheek if needed, repeat dose every 6 to 8 hours do not use more than 4 times a day Dosing Chart Weight (lb) Age (mos) Dose (mL) under 6 mos ask a doctor 12 to 17 lbs 6 to 11 mos 1.25 mL 18 to 23 lbs 12 to 23 mos 1.875 mL Other information store between 20° to 25°C (68° to 77°F) do not use if carton is opened or seal under cap is broken or missing"],"dosage_and_administration_table":["
Weight (lb) Age (mos) Dose (mL)
under 6 mos ask a doctor
12 to 17 lbs 6 to 11 mos 1.25 mL
18 to 23 lbs 12 to 23 mos 1.875 mL
"],"effective_time":"20240410","id":"2a48af51-23e2-4fec-a76b-eef1611750f5","inactive_ingredient":["Inactive ingredients acesulfame potassium, art raspberry flavor (contains propylene glycol), citric acid anhydrous, FD&C Red No. 40, glycerin, hypromellose, noncrystallizing sorbitol solution, polysorbate 80, pregelatinized starch (potato), purified water, sodium benzoate, sucrose, xanthan gum"],"indications_and_usage":["Uses temporarily: reduces fever relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches"],"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":["ANDA213506"],"brand_name":["Infants Ibuprofen"],"generic_name":["IBUPROFEN"],"is_original_packager":[true],"manufacturer_name":["Aurohealth LLC"],"nui":["N0000000160","M0001335","N0000175722"],"package_ndc":["58602-227-04","58602-227-07"],"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":["58602-227"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["204442"],"spl_id":["2a48af51-23e2-4fec-a76b-eef1611750f5"],"spl_set_id":["2a48af51-23e2-4fec-a76b-eef1611750f5"],"substance_name":["IBUPROFEN"],"unii":["WK2XYI10QM"]},"package_label_principal_display_panel":["PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 FL OZ (30 mL) Container Label AUROHEALTH NDC 58602-227-07 For Ages 6 Mos. to 23 Mos. Concentrated Infants' Drops Ibuprofen Oral Suspension, USP (NSAID) 50 mg per 1.25 mL Pain Reliever/Fever Reducer (NSAID) Concentrated Drops Lasts up to 8 hours Use only with enclosed syringe. Berry Flavor 1 fl oz (30 mL) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 FL OZ (30 mL) Container Label","PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 FL OZ (30 mL) Container Carton Label AUROHEALTH NDC 58602-227-07 # Compare to the active ingredient in Motrin ® Infants' Drops See New Warnings For Ages 6 Mos. to 23 Mos. Concentrated Infants ' Drops Ibuprofen Oral Suspension, USP (NSAID) 50 mg per 1.25 mL Pain Reliever/ Fever Reducer (NSAID) Concentrated Drops Lasts up to 8 hours Use only with enclosed syringe. Berry Flavor 1 fl oz (30 mL) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 FL OZ (30 mL) Carton Label"],"purpose":["Purpose Pain reliever/fever reducer"],"questions":["Questions or comments? Call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST) Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: TS/DRUGS/19/1993"],"set_id":"2a48af51-23e2-4fec-a76b-eef1611750f5","spl_product_data_elements":["Infants Ibuprofen Ibuprofen IBUPROFEN IBUPROFEN ACESULFAME POTASSIUM PROPYLENE GLYCOL ANHYDROUS CITRIC ACID FD&C RED NO. 40 GLYCERIN HYPROMELLOSE 2208 (4000 MPA.S) NONCRYSTALLIZING SORBITOL SOLUTION POLYSORBATE 80 STARCH, POTATO WATER SODIUM BENZOATE SUCROSE XANTHAN GUM Light Pink to Pink"],"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."],"when_using":["When using this product take with food or milk if stomach upset occurs"]}