{"active_ingredient":["ACTIVE INGREDIENT (IN EACH 5 ML) Ibuprofen 100 mg (NSAID)* *nonsteroidal anti-inflammatory drug"],"ask_doctor":["Ask a doctor before use if • stomach bleeding warning applies to the child • child has problems or serious side effects from taking pain relievers or fever reducers • child has a history of stomach problems, such as heartburn • child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, or had a stroke • child has not been drinking fluids • child has lost a lot of fluid due to vomiting or diarrhea • 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 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 below. If possible, use weight to dose; otherwise use age. • repeat dose every 6-8 hours , if needed • do not use more than 4 times a day • measure only with the dosing cup provided. Dosing cup to be used with Children's Advil Suspension only. Do not use with other products. Dose lines account for product remaining in cup due to thickness of suspension. Dosing Chart Weight (lb) Age (yr) Dose (mL) under 24 lb under 2 yr ask a doctor 24-35 lb 2-3 yr 5 mL 36-47 lb 4-5 yr 7.5 mL 48-59 lb 6-8 yr 10 mL 60-71 lb 9-10 yr 12.5 mL 72-95 lb 11 yr 15 mL"],"dosage_and_administration_table":["<table width=\"75%\"><col width=\"25%\"/><col width=\"25%\"/><col width=\"25%\"/><thead><tr><th align=\"center\" styleCode=\"Botrule Lrule Toprule \" valign=\"middle\"><content styleCode=\"bold\">Weight (lb)</content></th><th align=\"center\" styleCode=\"Botrule Toprule \" valign=\"middle\"><content styleCode=\"bold\">Age (yr)</content></th><th align=\"center\" styleCode=\"Rrule Botrule Toprule \" valign=\"middle\"><content styleCode=\"bold\">Dose (mL)</content></th></tr></thead><tbody><tr><td align=\"center\" styleCode=\"Lrule Toprule Botrule \" valign=\"middle\"><paragraph>under 24 lb</paragraph></td><td align=\"center\" styleCode=\"Toprule Botrule \" valign=\"middle\"><paragraph>under 2 yr</paragraph></td><td align=\"center\" styleCode=\"Rrule Toprule Botrule \" valign=\"middle\"><paragraph>ask a doctor</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Lrule Botrule \" valign=\"middle\"><paragraph>24-35 lb </paragraph></td><td align=\"center\" styleCode=\"Botrule \" valign=\"middle\"><paragraph>2-3 yr</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule \" valign=\"middle\"><paragraph>5 mL</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Lrule Botrule \" valign=\"middle\"><paragraph>36-47 lb </paragraph></td><td align=\"center\" styleCode=\"Botrule \" valign=\"middle\"><paragraph>4-5 yr</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule \" valign=\"middle\"><paragraph>7.5 mL</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Lrule Botrule \" valign=\"middle\"><paragraph>48-59 lb </paragraph></td><td align=\"center\" styleCode=\"Botrule \" valign=\"middle\"><paragraph>6-8 yr </paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule \" valign=\"middle\"><paragraph>10 mL</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Lrule Botrule \" valign=\"middle\"><paragraph>60-71 lb</paragraph></td><td align=\"center\" styleCode=\"Botrule \" valign=\"middle\"><paragraph>9-10 yr</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule \" valign=\"middle\"><paragraph>12.5 mL</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Botrule Lrule \" valign=\"middle\"><paragraph>72-95 lb</paragraph></td><td align=\"center\" styleCode=\"Botrule \" valign=\"middle\"><paragraph>11 yr</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule \" valign=\"middle\"><paragraph>15 mL</paragraph></td></tr></tbody></table>"],"effective_time":"20240208","id":"88972802-d04c-4fe3-8c56-3c3d1e3b4218","inactive_ingredient":["INACTIVE INGREDIENTS Children's Advil Suspension Fruit Flavor artificial flavor, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, FD&C red no. 40, glycerin, microcrystalline cellulose, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum Children's Advil Suspension Grape Flavor acetic acid, artificial flavor, butylated hydroxytoluene, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, FD&C blue no.1, FD&C red no. 40, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum Children's Advil Suspension Blue Raspberry Flavor artificial and natural flavors, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, FD&C blue no. 1, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucrose, xanthan gum Children's Advil Suspension White Grape Flavor acetic acid, artificial flavor, butylated hydroxytoluene, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum Children's Advil Suspension Bubblegum Flavor carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, FD&C red no. 40, glycerin, microcrystalline cellulose, natural and artificial flavor, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum Children's Advil Suspension Sugar-Free Dye-Free Berry artificial flavor, +orbate 80, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, 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."],"openfda":{"application_number":["NDA020589"],"brand_name":["CHILDRENS ADVIL"],"generic_name":["IBUPROFEN"],"is_original_packager":[true],"manufacturer_name":["Haleon US Holdings LLC"],"nui":["N0000000160","M0001335","N0000175722"],"package_ndc":["0573-0174-30","0573-0171-30","0573-0171-03","0573-0171-32","0573-0170-30","0573-0170-01","0573-0170-32","0573-0290-30","0573-0290-01","0573-0207-30","0573-0232-30"],"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":["0573-0170","0573-0174","0573-0171","0573-0290","0573-0207","0573-0232"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["197803","206878"],"spl_id":["88972802-d04c-4fe3-8c56-3c3d1e3b4218"],"spl_set_id":["3079d932-afb2-94fe-f4ba-a3d8b5198fce"],"substance_name":["IBUPROFEN"],"unii":["WK2XYI10QM"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 0573-0174-30 Children's Advil ® Suspension Ibuprofen Oral Suspension 100 mg per 5 mL Pain Reliever/Fever Reducer (NSAID) Fever Aches & Pains Lasts Up To 8 Hours BLUE RASPBERRY! Blue Raspberry-Flavored Liquid for ages 2-11 years 4 FL OZ (120 mL) Alcohol-Free 120 mL Bottle Carton Blue Raspberry","PRINCIPAL DISPLAY PANEL NDC 0573-0171-30 Children's Advil ® Suspension Ibuprofen Oral Suspension 100 mg per 5 mL Pain Reliever/Fever Reducer (NSAID) Fever Aches & Pains Lasts Up To 8 Hours Grape-Flavored Liquid for ages 2-11 years 4 FL OZ (120 mL) Alcohol-Free 120 mL Bottle Carton Grape","PRINCIPAL DISPLAY PANEL NDC 0573-0170-30 Children's Advil ® Suspension Ibuprofen Oral Suspension 100 mg per 5 mL Pain Reliever/Fever Reducer (NSAID) Fever Aches & Pains Lasts Up To 8 Hours Fruit-Flavored Liquid for ages 2-11 years 4 FL OZ (120 mL) Alcohol-Free 120 mL Bottle Carton Fruit","PRINCIPAL DISPLAY PANEL NDC0573-0290-30 Children's Advil ® Suspension Ibuprofen Oral Suspension 100 mg per 5 mL Pain Reliever/Fever Reducer (NSAID) Fever Aches & Pains Lasts Up To 8 Hours Dye-Free WHITE GRAPE White Grape-Flavored Liquid for ages 2-11 years 4 FL OZ (120 mL) Alcohol-Free 120 mL Bottle Carton White Grape","PRINCIPAL DISPLAY PANEL NDC 0573-0207-30 Children's Advil ® Suspension Ibuprofen Oral Suspension 100 mg per 5 mL Pain Reliever/Fever Reducer (NSAID) Fever Aches & Pains Lasts Up To 8 Hours Bubble Gum Bubble Gum-Flavored Liquid for ages 2-11 years 4 FL OZ (120 mL) Alcohol-Free 120 mL Bottle Carton Bubble Gum","PRINCIPAL DISPLAY PANEL NDC 0573-0232-30 SUGAR-FREE Children's Advil ® Suspension Ibuprofen Oral Suspension 100 mg per 5 mL Pain Reliever/Fever Reducer (NSAID) Fever Aches & Pains Lasts Up To 8 Hours Dye-Free BERRY Berry-Flavored Liquid for ages 2-11 years 4 FL OZ (120 mL) Alcohol-Free 120 mL Bottle Carton Berry"],"purpose":["PURPOSE Fever reducer/Pain reliever"],"questions":["QUESTIONS OR COMMENTS? call toll-free 1-800-88-ADVIL or ask your pharmacist, doctor or health care professional"],"set_id":"3079d932-afb2-94fe-f4ba-a3d8b5198fce","spl_product_data_elements":["CHILDRENS ADVIL ibuprofen IBUPROFEN IBUPROFEN CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED CITRIC ACID MONOHYDRATE EDETATE DISODIUM FD&C BLUE NO. 1 GLYCERIN MICROCRYSTALLINE CELLULOSE POLYSORBATE 80 PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCROSE XANTHAN GUM Translucent, medium dark blue CHILDRENS ADVIL ibuprofen IBUPROFEN IBUPROFEN ACETIC ACID BUTYLATED HYDROXYTOLUENE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED CITRIC ACID MONOHYDRATE EDETATE DISODIUM FD&C BLUE NO. 1 GLYCERIN MICROCRYSTALLINE CELLULOSE POLYSORBATE 80 PROPYLENE GLYCOL FD&C RED NO. 40 WATER SODIUM BENZOATE SORBITOL SUCROSE XANTHAN GUM Translucent purple CHILDRENS ADVIL ibuprofen IBUPROFEN IBUPROFEN CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED CITRIC ACID MONOHYDRATE EDETATE DISODIUM FD&C RED NO. 40 GLYCERIN MICROCRYSTALLINE CELLULOSE POLYSORBATE 80 WATER SODIUM BENZOATE SORBITOL SUCROSE XANTHAN GUM Translucent red CHILDRENS ADVIL ibuprofen IBUPROFEN IBUPROFEN ACETIC ACID BUTYLATED HYDROXYTOLUENE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED CITRIC ACID MONOHYDRATE EDETATE DISODIUM GLYCERIN MICROCRYSTALLINE CELLULOSE POLYSORBATE 80 PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SUCROSE XANTHAN GUM CHILDRENS ADVIL ibuprofen IBUPROFEN IBUPROFEN CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED CITRIC ACID MONOHYDRATE EDETATE DISODIUM FD&C RED NO. 40 GLYCERIN MICROCRYSTALLINE CELLULOSE POLYSORBATE 80 PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SUCROSE XANTHAN GUM CHILDRENS ADVIL ibuprofen IBUPROFEN IBUPROFEN CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED CITRIC ACID MONOHYDRATE EDETATE DISODIUM GLYCERIN MICROCRYSTALLINE CELLULOSE POLYSORBATE 80 PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCRALOSE XANTHAN GUM"],"spl_unclassified_section":["OTHER INFORMATION Children's Advil Suspension Fruit Flavor; Children's Advil Suspension Grape Flavor; Children's Advil Suspension White Grape Flavor; Children's Advil Bubblegum • each 5 mL contains: sodium 3 mg • one dose lasts 6-8 hours • store at 20-25°C (68-77°F) • see bottom of box for lot number and expiration date Children's Advil Suspension Blue Raspberry Flavor; Children's Advil Suspension Sugar-Free Dye-Free Berry Flavor • each 5 mL contains: sodium 10 mg • one dose lasts 6-8 hours • store at 20-25°C (68-77°F) • see bottom of box for lot number and expiration date"],"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":"20","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 the 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 any other pain reliever/fever reducer • right before or after heart surgery Ask a doctor before use if • stomach bleeding warning applies to the child • child has problems or serious side effects from taking pain relievers or fever reducers • child has a history of stomach problems, such as heartburn • child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, or had a stroke • child has not been drinking fluids • child has lost a lot of fluid due to vomiting or diarrhea • 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."],"when_using":["When using this product • take with food or milk if stomach upset occurs"]}