{"active_ingredient":["Active ingredient (in each 0.8 mL) Acetaminophen 80 mg"],"ask_doctor":["Ask a doctor before use if your child has liver disease"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if your child is taking the blood-thinning drug warfarin"],"do_not_use":["Do not use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • if your child is allergic to acetaminophen or any of the inactive ingredients in this product."],"dosage_and_administration":["Directions This product does not contain directions or complete warnings for adult use. • USE A DOSING DEVICE to give this medicine • use weight, if possible, to dose; otherwise use age • Fill to dose level. • Dispense liquid slowly into child's mouth, toward inner cheek. • if needed, repeat dose every 4 hours while symptoms last. • do not give more than 5 doses in 24 hours • Children 2 to 3 years or 24 to 35 pounds: 2 dropperfuls (2 x 0.8 mL). • Children under 2 years or under 24 pounds: ask a doctor"],"effective_time":"20180220","id":"ecdf5281-6d13-40fb-8fe4-4d1eba2e19c3","inactive_ingredient":["Inactive Ingredients artificial fruit flavor, artificial orange flavor, butylparaben, citric acid, FD&C Yellow #6, glycerin, polyethylene glycol 1450, propylene glycol, purified water, saccharin, sodium citrate."],"indications_and_usage":["Uses temporarily: • reduces fever • relieves minor aches and pains due to: • cold • flu • headache • sore throat • toothache"],"keep_out_of_reach_of_children":["Keep out of reach of children"],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton NDC 0904-5901-35 MAJOR ® INFANTS' TAMPER-EVIDENT Māpap ® (acetaminophen 80 mg per 0.8 mL) PAIN RELIEVER/ FEVER REDUCER FRUIT FLAVOR Fast, Effective Relief of Infants' Fever and Pain ALCOHOL-FREE ASPIRIN-FREE IBUPROFEN-FREE 1/2 FL OZ (15 mL) Compare to active ingredient of Infants' TYLENOL ® Drops* Principal Display Panel - 15 mL Bottle Carton"],"purpose":["Purpose Pain reliever / fever reducer"],"questions":["Questions? Adverse Drug Event Call (800) 616-2471"],"set_id":"b36dbb9b-cbfa-4a62-a8bd-d7ae28e66389","spl_product_data_elements":["INFANTS MAPAP Pain Reliever /Fever Reducer Acetaminophen Acetaminophen Acetaminophen Citric Acid Monohydrate Glycerin Polyethylene Glycol 1450 Propylene Glycol Water SODIUM CITRATE, UNSPECIFIED FORM Saccharin Butylparaben FD&C Yellow no. 6"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if • pain gets worse or lasts more than 5 days • fever gets worse or last for more than 3 days • new symptoms occur • redness or swelling is present These could be signs of a serious condition."],"storage_and_handling":["Other Information • TAMPER-EVIDENT: Do not use this product if inner foil seal over the mouth of the bottle is cut, torn, broken or missing. • keep tightly closed • store at room temperature"],"version":"2","warnings":["Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if your child takes • more than 5 doses in 24 hours, which is maximum daily amount • with other drugs containing acetaminophen. Sore throat warning if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • if your child is allergic to acetaminophen or any of the inactive ingredients in this product. Ask a doctor before use if your child has liver disease Ask a doctor or pharmacist before use if your child is taking the blood-thinning drug warfarin When using this product, do not exceed recommended dose (see overdose warning) Stop use and ask a doctor if • pain gets worse or lasts more than 5 days • fever gets worse or last for more than 3 days • new symptoms occur • redness or swelling is present These could be signs of a serious condition. Keep out of reach of children Overdose warning Taking more than recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"when_using":["When using this product, do not exceed recommended dose (see overdose warning)"]}