{ "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": 1 } }, "results": [ { "spl_product_data_elements": [ "Infants Ibuprofen Infants Ibuprofen IBUPROFEN IBUPROFEN ANHYDROUS CITRIC ACID GLYCERIN POLYSORBATE 80 STARCH, CORN WATER SODIUM BENZOATE SUCROSE XANTHAN GUM SORBITOL Mixed Berry" ], "active_ingredient": [ "ACTIVE INGREDIENT (in each 1.25 mL) Ibuprofen, USP 50 mg (NSAID)* *nonsteroidal anti-inflammatory drug" ], "purpose": [ "PURPOSE Pain reliever/ fever reducer" ], "indications_and_usage": [ "USE(S) temporarily: reduces fever relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches" ], "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 you 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 ibuprofen or 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 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" ], "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 find right dose on chart below. If possible, use weight to dose; otherwise use age. mL=milliliter measure with dosing device provided. Do not use any other dosing device. dispense liquid slowly into the child's mouth, toward the inner cheek if needed, repeat dose every 6-8 hours do not use more than 4 times a day Dosing Chart WEIGHT (lb) AGE (mos) DOSE (mL) under 6 mos ask a doctor 12-17 lbs 6-11 mos 1.25 mL 18-23 lbs 12-23 years 1.875 mL" ], "dosage_and_administration_table": [ "
WEIGHT (lb) AGE (mos) DOSE (mL)
under 6 mos ask a doctor
12-17 lbs 6-11 mos 1.25 mL
18-23 lbs 12-23 years 1.875 mL
" ], "storage_and_handling": [ "OTHER INFORMATION store between 20-25 o C (68-77 o F) do not use if carton is opened or if printed neckband is imprinted with \"SEALED FOR YOUR PROTECTION\" and \"USE WITH ENCLOSED DOSING DEVICE ONLY\" is broken or missing." ], "inactive_ingredient": [ "INACTIVE INGREDIENTS anhydrous citric acid, flavors, glycerin, polysorbate 80, pregelatinized starch, purified water, sodium benzoate, sorbitol, sucrose, xanthan gum." ], "spl_unclassified_section": [ "QUESTIONS OR COMMENTS? call 1-609-860-2600 (Monday - Friday 8 am - 4 pm)" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL FAMILY Wellness TM COMPARE TO THE ACTIVE INGREDIENT IN INFANTS' MOTRIN ® * infants' IBUPROFEN CONCENTRATED DROPS ORAL SUSPENSION CONCENTRATED DROPS ORAL SUSPENSION AGES 6 MONTHS TO 23 MONTHS 50 mg per 1.25 mL Pain Reliever/Fever Reducer (NSAID) Use only with enclosed syringe DYE-FREE BERRY FLAVOR 1 FL OZ (30 mL) fw-637-carton.jpg" ], "set_id": "13143eb6-2fe8-487b-e063-6294a90a967e", "id": "e1e7c996-307e-41d3-a1f2-a1f2c6567f8d", "effective_time": "20240327", "version": "2", "openfda": { "application_number": [ "ANDA210755" ], "brand_name": [ "Infants Ibuprofen" ], "generic_name": [ "INFANTS IBUPROFEN" ], "manufacturer_name": [ "Family Dollar Services, Inc." ], "product_ndc": [ "55319-637" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "IBUPROFEN" ], "rxcui": [ "204442" ], "spl_id": [ "e1e7c996-307e-41d3-a1f2-a1f2c6567f8d" ], "spl_set_id": [ "13143eb6-2fe8-487b-e063-6294a90a967e" ], "package_ndc": [ "55319-637-09" ], "is_original_packager": [ true ], "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" ] } } ] }