{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-06-02", "results": { "skip": 0, "limit": 1, "total": 14 } }, "results": [ { "spl_product_data_elements": [ "Ibuprofen Oral Ibuprofen Oral ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED D&C YELLOW NO. 10 GLYCERIN FD&C RED NO. 40 MICROCRYSTALLINE CELLULOSE POLYSORBATE 80 PROPYLENE GLYCOL WATER SODIUM BENZOATE SUCROSE XANTHAN GUM IBUPROFEN IBUPROFEN" ], "active_ingredient": [ "ACTIVE INGREDIENT(S) (in each 5 mL) Ibuprofen 100 mg (NSAID)* *nonsteroidal anti-inflammatory drug" ], "purpose": [ "PURPOSE Pain reliever/fever reducer" ], "indications_and_usage": [ "USE(S) temporarily: relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache reduces fever" ], "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": [ "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_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" ], "when_using": [ "WHEN USING THIS PRODUCT take with food or milk if stomach upset occurs" ], "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" ], "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)" ], "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) under 24 24-35 lbs 36-47 lbs 48-59 lbs 60-71 lbs 72-95 lbs Age (yr) under 2 years 2-3 years 4-5 years 6-8 years 9-10 years 11 years Dose (mL)* ask a doctor 5 mL 7.5 mL 10 mL 12.5 mL 15 mL *or as directed by a doctor" ], "dosage_and_administration_table": [ "
Weight (lb) under 24 24-35 lbs 36-47 lbs 48-59 lbs 60-71 lbs 72-95 lbs Age (yr) under 2 years 2-3 years 4-5 years 6-8 years 9-10 years 11 years Dose (mL)* ask a doctor 5 mL 7.5 mL 10 mL 12.5 mL 15 mL
" ], "spl_unclassified_section": [ "Other information  each 5 mL contains : sodium 2 mg store between 20-25°C (68-77°F) do not use if carton is opened or printed bottle neckband is broken or missing see bottom panel for lot number and expiration date How Supplied Ibuprofen 100 mg (NSAID)* 72162-1909-02: Bottle of 118 mL Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504" ], "inactive_ingredient": [ "INACTIVE INGREDIENT SECTION Berry flavor (with dye) Acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, D&C Yellow #10, FD&C Red #40, flavors, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sucrose, and xanthan gum. Berry flavor (dye free) Acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sucrose, and xanthan gum. Grape flavor Acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, D&C Red #33, FD&C Blue #1, flavors, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sucrose, and xanthan gum. Bubble Gum flavor Acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, D&C Red #33, FD&C Red #40, flavors, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sucrose, and xanthan gum." ], "questions": [ "QUESTIONS SECTION Call 1-888-588-1418 from 9 AM to 5 PM EST, Monday-Friday. Distributed by: Camber Consumer Care, Inc. Piscataway, NJ 08854, USA ibuprofencamberlogo" ], "package_label_principal_display_panel": [ "Ibuprofen 100 mg/5ml Oral Suspension Label" ], "set_id": "34f88afb-5c56-ca2c-e063-6394a90a9072", "id": "34f87cb5-33ec-b8ce-e063-6394a90a515b", "effective_time": "20250512", "version": "100", "openfda": { "application_number": [ "ANDA210602" ], "brand_name": [ "Ibuprofen Oral" ], "generic_name": [ "IBUPROFEN ORAL" ], "manufacturer_name": [ "Bryant Ranch Prepack" ], "product_ndc": [ "72162-1909" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "IBUPROFEN" ], "rxcui": [ "197803" ], "spl_id": [ "34f87cb5-33ec-b8ce-e063-6394a90a515b" ], "spl_set_id": [ "34f88afb-5c56-ca2c-e063-6394a90a9072" ], "package_ndc": [ "72162-1909-2" ], "original_packager_product_ndc": [ "69230-308" ], "nui": [ "N0000000160", "M0001335", "N0000175722" ], "pharm_class_moa": [ "Cyclooxygenase Inhibitors [MoA]" ], "pharm_class_cs": [ "Anti-Inflammatory Agents, Non-Steroidal [CS]" ], "pharm_class_epc": [ "Nonsteroidal Anti-inflammatory Drug [EPC]" ], "unii": [ "WK2XYI10QM" ] } } ] }