{"active_ingredient":["Active ingredient (in each 5 mL) Acetaminophen 160 mg"],"ask_doctor":["Ask a doctor before use if the user • has liver disease • is a child with pain of arthritis","Stop use and ask a doctor if adult's pain gets worse or lasts more than 10 days child's 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"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if the user 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 you are allergic to aetaminophen or any of the inactive ingredients of this product"],"dosage_and_administration":["Directions do not take more than directed (see overdose warning ) dose product from the single dose cup the product is packaged in mL=milliliter age dose adults and children 12 years of age and over 20 mL (640 mg) every 4 to 6 hours not to exceed 6 doses in a 24-hour period children 6 to under 12 years of age 10 mL (320 mg) every 4 hours not to exceed 5 doses in a 24-hour period children 4 to under 6 years of age 7.5 mL (240 mg) every 4 hours not to exceed 5 doses in a 24-hour period children 2 to under 4 years of age 5 mL (160 mg) every 4 hours not to exceed 5 doses in a 24-hour period children under 2 years of age consult a doctor"],"dosage_and_administration_table":["
age dose
adults and children 12 years of age and over20 mL (640 mg) every 4 to 6 hours not to exceed 6 doses in a 24-hour period
children 6 to under 12 years of age10 mL (320 mg) every 4 hours not to exceed 5 doses in a 24-hour period
children 4 to under 6 years of age7.5 mL (240 mg) every 4 hours not to exceed 5 doses in a 24-hour period
children 2 to under 4 years of age5 mL (160 mg) every 4 hours not to exceed 5 doses in a 24-hour period
children under 2 years of ageconsult a doctor
"],"effective_time":"20251211","id":"ba8d56c1-521e-490b-a83e-ebfa2d51bd8b","inactive_ingredient":["Inactive ingredients anhydrous citric acid, edetate disodium, flavor, glycerin, polyethylene glycol 400, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose, trisodium citrate dihydrate"],"indications_and_usage":["Uses • for the temporary relief of minor aches and pains due to headache muscular aches backache sore throat flu the common cold toothache premenstrual and menstrual cramps • for the minor pain from arthritis • and to reduce fever"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{"application_number":["M013"],"brand_name":["Acetaminophen"],"generic_name":["ACETAMINOPHEN"],"is_original_packager":[true],"manufacturer_name":["PAI Holdings, LLC dba PAI Pharma"],"package_ndc":["0121-1047-05","0121-1047-00"],"product_ndc":["0121-1047"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["307675"],"spl_id":["ba8d56c1-521e-490b-a83e-ebfa2d51bd8b"],"spl_set_id":["fac4e0c6-684f-45a1-99f2-de4de4017cc8"],"substance_name":["ACETAMINOPHEN"],"unii":["362O9ITL9D"]},"overdosage":["Overdose warning: Taking more than the 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 children even if you do not notice any signs or symptoms."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 5 mL Cup Delivers 5 mL NDC 0121-1047-05 Acetaminophen Oral Solution USP 160 mg/5 mL Pain Reliever/Fever Reducer Alcohol Free/Dye Free/Sugar Free Grape Flavored Package Not Child-Resistant Dist. by: PAI Pharma GREENVILLE, SC 29605 See insert for drug facts lidding for 5 mL Acetaminophen FN1047 cup"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purposes Pain reliever/fever reducer"],"questions":["Questions or comments? Call 1-800-845-8210. You may also report serious side effects to this phone number."],"set_id":"fac4e0c6-684f-45a1-99f2-de4de4017cc8","spl_product_data_elements":["Acetaminophen Acetaminophen ACETAMINOPHEN ACETAMINOPHEN ANHYDROUS CITRIC ACID EDETATE DISODIUM GLYCERIN POLYETHYLENE GLYCOL 400 WATER SODIUM BENZOATE SODIUM METABISULFITE SORBITOL SUCRALOSE SODIUM CITRATE"],"spl_unclassified_section":["Distributed by: PAI Pharma Greenville,SC 29605 www.paipharma.com R05/25"],"storage_and_handling":["Other information ■ Each 5 mL contains: sodium 6 mg ■ store at 20° to 25°C (68° to 77°F)"],"version":"3","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult takes more than 6 doses in 24 hours, which is the maximum daily amount child takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day while using this product 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."]}