{"active_ingredient":["Active ingredient (in each 5 mL = teaspoonful) Ibuprofen 100 mg (NSAID)* *nonsteroidal anti-inflammatory drug Pseudoephedrine HCl 15 mg"],"ask_doctor":["Ask a doctor before use if • child has problems or serious side effects from taking pain relievers, fever reducers or nasal decongestants • the stomach bleeding warning applies to your child • child has a history of stomach problems, such as heartburn • 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, or kidney disease • child has asthma • child has thyroid disease • child has diabetes • child is taking a diuretic"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if the child is • taking any other drug containing pseudoephedrine or any other nasal decongestant • 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 and/or nasal decongestant • right before or after heart surgery • in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product."],"dosage_and_administration":["Directions • this product does not contain directions or complete warnings for adult use • do not give more than directed • do not give longer than 10 days, unless directed by a doctor (see Warnings) • shake well before using • find right dose on chart below. If possible, use weight to dose; otherwise use age. • only use enclosed measuring cup • if needed, repeat dose every 6 hours • do not use more than 4 times a day • replace original bottle cap to maintain child resistance • wash dosage cup after each use Dosing Chart Weight (lb) Age (yrs) Dose (tsp or mL) under 4 years ask a doctor 36-47 lbs 4 to 5 years 1 tsp or 5 mL 48-95 lbs 6 to 11 years 2 tsp or 10 mL"],"dosage_and_administration_table":["
Dosing Chart
Weight (lb) Age (yrs) Dose (tsp or mL)
under 4 years ask a doctor
36-47 lbs 4 to 5 years 1 tsp or 5 mL
48-95 lbs 6 to 11 years 2 tsp or 10 mL
"],"effective_time":"20161012","id":"7c4fcf05-ebe0-485c-aae9-eb43908da56f","inactive_ingredient":["Inactive ingredients acesulfame potassium, anhydrous citric acid, D&C yellow #10, FD&C red #40, flavor, glycerin, high fructose corn syrup, hypromellose, polysorbate 80, purified water, sodium benzoate, xanthan gum"],"indications_and_usage":["Uses • temporarily relieves these cold, sinus and flu symptoms: • nasal and sinus congestion • stuffy nose • headache • sore throat • minor body aches and pains • 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":{},"package_label_principal_display_panel":["Principal Display Panel Compare to the active ingredients in Children's Motrin® Cold Berry Flavor See new warnings information See new dosing directions For ages 4 to 11 Children's IBUPROFEN COLD RELIEF IBUPROFEN/PSEUDOEPHEDRINE HCl ORAL SUSPENSION 100 mg/15 mg per 5 mL (teaspoonful) Pain reliever/Fever reducer (NSAID) Nasal decongestant Relieves: Stuffy nose (Pseudoephedrine HCl) Sore throat (Ibuprofen) Fever (Ibuprofen) Berry Flavor ALCOHOL-FREE Ibuprofen Cold Relief Carton Image 1 Ibuprofen Cold Relief Carton Image 1 Ibuprofen Cold Relief Carton Image 2 Ibuprofen Cold Relief Carton Image 1 Ibuprofen Cold Relief Carton Image 2"],"purpose":["Purpose Pain reliever/fever reducer Nasal decongestant"],"questions":["Questions or comments? 1-800-719-9260"],"set_id":"3a667c4c-b67a-4db7-a5dc-0a6199b435c7","spl_product_data_elements":["ibuprofen cold relief childrens Ibuprofen, Pseudoephedrine HCl IBUPROFEN IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID HIGH FRUCTOSE CORN SYRUP D&C YELLOW NO. 10 FD&C RED NO. 40 GLYCERIN HYPROMELLOSES POLYSORBATE 80 WATER SODIUM BENZOATE XANTHAN GUM opaque, viscous"],"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 • the child does not get any relief within first day (24 hours) of treatment • fever, pain or nasal congestion gets worse or lasts more than 3 days • redness or swelling is present in the painful area • any new symptoms appear • the child gets nervous, dizzy or sleepless"],"storage_and_handling":["Other information • do not use if printed neckband is broken or missing • store at 20-25°C (68-77°F) • see bottom of box for lot number and expiration date"],"version":"2","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 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 and/or nasal decongestant • right before or after heart surgery • in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if • child has problems or serious side effects from taking pain relievers, fever reducers or nasal decongestants • the stomach bleeding warning applies to your child • child has a history of stomach problems, such as heartburn • 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, or kidney disease • child has asthma • child has thyroid disease • child has diabetes • child is taking a diuretic Ask a doctor or pharmacist before use if the child is • taking any other drug containing pseudoephedrine or any other nasal decongestant • under a doctor’s care for any serious condition • taking any other drug When using this product • do not exceed recommended dosage • give with food or milk if stomach upset occurs • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed 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 • the child does not get any relief within first day (24 hours) of treatment • fever, pain or nasal congestion gets worse or lasts more than 3 days • redness or swelling is present in the painful area • any new symptoms appear • the child gets nervous, dizzy or sleepless 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 • do not exceed recommended dosage • give with food or milk if stomach upset occurs • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed"]}