{"active_ingredient":["Active ingredient (in each 5 mL teaspoonful) ACETAMINOPHEN 160 mg"],"ask_doctor":["Ask a doctor before use if the user has liver disease"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if the user is taking the blood thining 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. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor if you are allergic to acetaminophen or any of the inactive ingredients of this product"],"dosage_and_administration":["Directions do not take more than directed (see overdose warning ) age dose adults and children 12 years of age and over 20.3 mL (650 mg) every 4 to 6 hours not to exceed 6 doses in a 24-hour period children 6 to under 12 years of age 10.15 mL (325 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":["
agedose
adults and children 12 years of age and over20.3 mL (650 mg) every 4 to 6 hours not to exceed 6 doses in a 24-hour period
children 6 to under 12 years of age10.15 mL (325 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":"20240812","id":"1f8166c0-62db-10f8-e063-6394a90a86cf","inactive_ingredient":["Inactive ingredients: Citric acid, FD&C Red No. 40, flavoring, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol and sucrose."],"indications_and_usage":["Uses temporarily relieves minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache premenstrual and menstrual cramps temporarily reduces 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":["0121-0657-05","0121-0657-00","0121-0657-11","0121-0657-21","0121-1314-11","0121-1314-00","0121-1971-21","0121-1971-00"],"product_ndc":["0121-0657","0121-1314","0121-1971"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["307675"],"spl_id":["1f8166c0-62db-10f8-e063-6394a90a86cf"],"spl_set_id":["6ec12573-03d6-40c1-9945-d345b401e062"],"substance_name":["ACETAMINOPHEN"],"unii":["362O9ITL9D"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 5 mL Cup Delivers 5 mL NDC 0121-0657-05 Acetaminophen Oral Solution USP 160 mg/5 mL ALCOHOL FREE Package Not Child-Resistant PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 SEE INSERT F0657051020 20 mL Unit Dose Cup Label","PRINCIPAL DISPLAY PANEL - 10 mL Cup Delivers 10.15 mL NDC 0121-1314-11 Acetaminophen Oral Solution USP 325 mg/10.15 mL ALCOHOL FREE Package Not Child-Resistant PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 SEE INSERT F0657111020 10 mL Unit Dose Cup Label","PRINCIPAL DISPLAY PANEL - 20.3 mL Cup Delivers 20.3 mL NDC 0121-1971-21 Acetaminophen Oral Solution USP 650 mg/20.3 mL ALCOHOL FREE Package Not Child-Resistant PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 SEE INSERT F0657211020 20.3 mL Unit Dose Cup Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose 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":"6ec12573-03d6-40c1-9945-d345b401e062","spl_product_data_elements":["Acetaminophen Acetaminophen ANHYDROUS CITRIC ACID FD&C RED NO. 40 GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE SORBITOL SUCROSE ACETAMINOPHEN ACETAMINOPHEN clear, red liquid Acetaminophen Acetaminophen FD&C RED NO. 40 GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE SORBITOL SUCROSE ANHYDROUS CITRIC ACID ACETAMINOPHEN ACETAMINOPHEN Acetaminophen Acetaminophen ANHYDROUS CITRIC ACID FD&C RED NO. 40 GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE SORBITOL SUCROSE ACETAMINOPHEN ACETAMINOPHEN"],"spl_unclassified_section":["MANUFACTURED BY: Pharmaceutical Associates, Inc. Greenville, SC 29605 www.paipharma.com R10/20"],"stop_use":["Stop use and ask a doctor if symptoms do not improve new symptoms occur pain or fever persists or gets worse"],"storage_and_handling":["Other information ■ Each 5 mL contains: sodium 2 mg ■ store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] ■ keep tightly closed ■ protect from light ■ a red, cherry flavored solution supplied in the following oral dosage forms: NDC 0121-0657-05: 5 mL unit dose cup NDC 0121-0657-00: Case contains 100 unit dose cups of 5 mL (0121-0657-05) packaged in 10 trays of 10 unit dose cups each. NDC 0121-1314-11: 10.15 mL unit dose cup NDC 0121-1314-00: Case contains 100 unit dose cups of 10.15 mL (0121-1314-11) packaged in 10 trays of 10 unit dose cups each. NDC 0121-1971-21: 20.3 mL unit dose cup NDC 0121-1971-00: Case contains 100 unit dose cups of 20.3 mL (0121-1971-21) packaged in 10 trays of 10 unit dose cups each."],"version":"15","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. 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. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor if you are allergic to acetaminophen or any of the inactive ingredients of this product Ask a doctor before use if the user has liver disease Ask a doctor or pharmacist before use if the user is taking the blood thining drug warfarin. Stop use and ask a doctor if symptoms do not improve new symptoms occur pain or fever persists or gets worse If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. 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."]}