{"active_ingredient":["Active ingredient (in each 5 mL teaspoonful) Acetaminophen, USP 160 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."],"dosage_and_administration":["Directions this product does not contain directions or complete warnings for adult use use only the enclosed dosing cup designed for use with this product if possible, use weight to dose, otherwise use age dose may be repeated every 4 hours, while symptoms persist, up to five times a day or as directed by a doctor Weight (lbs.) Age (years) Dosage Teaspoonful (tsp) or as directed by a doctor Under 24 Under 2 Consult a doctor 24 to 35 2 to under 4 5 mL (1 tsp) 36 to 47 4 to under 6 7.5 mL (1 1/2 tsp) 48 to 59 6 to under 9 10 mL (2 tsp) 60 to 71 9 to under 11 12.5 mL (2 1/2 tsp) 72 to 95 11 to under 12 15 mL (3 tsp)"],"dosage_and_administration_table":["
Weight (lbs.)Age (years)Dosage Teaspoonful (tsp)or as directed by a doctor
Under 24Under 2Consult a doctor
24 to 352 to under 45 mL (1 tsp)
36 to 474 to under 67.5 mL (1 1/2 tsp)
48 to 596 to under 910 mL (2 tsp)
60 to 719 to under 1112.5 mL (2 1/2 tsp)
72 to 9511 to under 1215 mL (3 tsp)
"],"effective_time":"20210504","id":"f382f280-b5cf-4f4b-869b-285ed012c19e","inactive_ingredient":["Inactive ingredients Cherry Flavor, Citric Acid, FD&C Red No. 40, Glycerin, Polyethylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Sorbitol Solution, Sucralose."],"indications_and_usage":["Uses For the temporary relief of minor aches and pains associated with: the common cold flu sore throat headache toothache and to reduce 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"openfda":{"application_number":["M013"],"brand_name":["Acetaminophen"],"generic_name":["ACETAMINOPHEN"],"is_original_packager":[true],"manufacturer_name":["Westminster Pharmaceuticals, LLC"],"package_ndc":["69367-323-04","69367-323-16"],"product_ndc":["69367-323"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["307675"],"spl_id":["f382f280-b5cf-4f4b-869b-285ed012c19e"],"spl_set_id":["ace5ebac-ec11-4c26-b1e3-954b450ee671"],"substance_name":["ACETAMINOPHEN"],"unii":["362O9ITL9D"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label NDC 69367-323-04 Children's Acetaminophen Liquid 160 mg/5 mL Pain Reliever / Fever Reducer Sugar Free / Alcohol Free Aspirin Free CHERRY FLAVOR 4 fl. oz. (118 mL) Westminster Pharmaceuticals PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label"],"purpose":["Purpose Pain reliever/fever reducer"],"questions":["Questions? You may report side effects by calling Westminster M-F (9 a.m. to 5 p.m. EST), at 1-844-221-7294 or FDA at 1-800-FDA-1088."],"set_id":"ace5ebac-ec11-4c26-b1e3-954b450ee671","spl_product_data_elements":["Acetaminophen Acetaminophen ACETAMINOPHEN ACETAMINOPHEN CITRIC ACID MONOHYDRATE FD&C RED NO. 40 POLYETHYLENE GLYCOL, UNSPECIFIED WATER SORBITOL SUCRALOSE SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SACCHARIN SODIUM"],"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 lasts more than 3 days redness or swelling is present any new symptoms appear. These could be signs of a serious condition."],"storage_and_handling":["Other information Each 5 mL contains: Sodium 3 mg If dispensed, dispense in a tight, light resistant container with a child-resistant cap. Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F)"],"version":"6","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 the maximum daily amount with other drugs that contain acetaminophen Allergy alert Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. 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. 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. Stop use and ask a doctor if pain gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days redness or swelling is present any new symptoms appear. These could be signs of a serious condition. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."]}