{"active_ingredient":["Active ingredients (in each 5 mL = 1 teaspoon) Ibuprofen 100 mg (NSAID) nonsteroidal anti-inflammatory drug Pseudoephedrine HCl 15 mg"],"ask_doctor":["Ask a doctor before use if the child has problems or serious side effects from taking pain relievers, fever reducers, or nasal decongestants stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain ulcers bleeding problems not been drinking fluids lost a lot of fluid due to vomiting or diarrhea high blood pressure heart or kidney disease asthma thyroid disease diabetes taken a diuretic"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if the child is taking any other drug containing an NSAID (prescription or nonprescription) and/or pseudoephedrine or any other nasal decongestant taking a blood thinning (anticoagulant) or steroid drug 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 Dosing Chart Weight (lb) Age (yrs) Dose (tsp or mL) under 24 under 2 ask a doctor 24-47 2 to 5 1 tsp or 5 mL 48-95 6 to 11 2 tsp or 10 mL"],"dosage_and_administration_table":["
Dosing Chart
Weight (lb) Age (yrs) Dose (tsp or mL)
under 24 under 2 ask a doctor
24-47 2 to 5 1 tsp or 5 mL
48-95 6 to 11 2 tsp or 10 mL
"],"effective_time":"20131108","id":"68248a98-3b9f-426d-ac1b-33dfd68aa030","inactive_ingredient":["Inactive ingredients acesulfame potassium, anhydrous citric acid, D&C yellow #10, FD&C red #40, flavors, glycerin, polysorbate 80, pregelatinized starch, purified water, sodium benzoate, sucrose, 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 NDC 50580-902-04 For Ages 2 to 11 Children's Motrin ® COLD contains Ibuprofen (NSAID) Pseudoephedrine HCl Oral Suspension 100 mg/15 mg per 5 mL (teaspoon) Pain Reliever/Fever Reducer/Nasal Decongestant Relieves: Stuffy Nose (Pseudoephedrine HCl) Sore Throat (Ibuprofen) Fever (Ibuprofen) Original Berry Flavor Alcohol Free 4 FL OZ (120 mL) PRINCIPAL DISPLAY PANEL - 120 mL Carton"],"purpose":["Purpose Pain reliever/fever reducer Nasal decongestant"],"questions":["Questions or comments? Call 1-877-895-3665 ( English ) or 1-888-466-8746 ( Spanish ): weekdays 9:00 AM to 4:30 PM EST"],"set_id":"7d28682b-fc7d-4c2b-9a83-89df25b5ab2d","spl_product_data_elements":["Childrens Motrin Cold Ibuprofen and Pseudoephedrine Hydrochloride Ibuprofen Ibuprofen Pseudoephedrine Hydrochloride Pseudoephedrine acesulfame potassium anhydrous citric acid D&C yellow no. 10 FD&C red no. 40 glycerin polysorbate 80 water sodium benzoate sucrose xanthan gum"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if the child feels faint, vomits blood, or has bloody or black stools. These are signs of stomach bleeding. stomach pain or upset gets worse or lasts 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 store between 20-25°C (68-77°F) do not use if bottle wrap, or foil inner seal imprinted with \"Safety Seal ® \" is broken or missing see bottom panel 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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 an NSAID (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 the child has problems or serious side effects from taking pain relievers, fever reducers, or nasal decongestants stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain ulcers bleeding problems not been drinking fluids lost a lot of fluid due to vomiting or diarrhea high blood pressure heart or kidney disease asthma thyroid disease diabetes taken a diuretic Ask a doctor or pharmacist before use if the child is taking any other drug containing an NSAID (prescription or nonprescription) and/or pseudoephedrine or any other nasal decongestant taking a blood thinning (anticoagulant) or steroid drug under a doctor's care for any serious condition taking any other drug When using this product do not exceed recommended dosage take 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 the child feels faint, vomits blood, or has bloody or black stools. These are signs of stomach bleeding. stomach pain or upset gets worse or lasts 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 take 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"]}