{"active_ingredient":["Active ingredient (in each 5 mL) Acetaminophen 160 mg"],"ask_doctor":["Ask a doctor before use if you have liver disease."],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are 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 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 his product"],"dosage_and_administration":["Directions Do not take more than directed (see overdose warning ) Use the following dosage guidelines when using this product 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":"20240521","id":"3fe345ab-3f0f-4111-afa2-d8d76ee1c410","inactive_ingredient":["Inactive Ingredients Citric acid, FD&C Red No. 40, flavoring, glycerin, polyethylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, and sorbitol."],"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 Solution"],"generic_name":["ACETAMINOPHEN"],"is_original_packager":[true],"manufacturer_name":["Patrin Pharma, Inc."],"package_ndc":["39328-031-05","39328-031-50","39328-031-99","39328-032-10","39328-032-50","39328-032-99","39328-034-20","39328-034-50","39328-034-99"],"product_ndc":["39328-031","39328-032","39328-034"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["307675"],"spl_id":["3fe345ab-3f0f-4111-afa2-d8d76ee1c410"],"spl_set_id":["52ae729b-2255-420c-8db8-cabdc2b74796"],"substance_name":["ACETAMINOPHEN"],"unii":["362O9ITL9D"],"upc":["0339328031053","0339328032104","0339328034207"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 5 mL Cup Label Delivers 5 mL NDC 39328-031-05 Acetaminophen Oral Solution USP 160 mg/5 mL Alcohol Free For Institutional Use Only See Insert Lot# xxxxxx Exp: yyyy/mm/dd Patrin Pharma Skokie, IL 60076 Rev 03.0324 PRINCIPAL DISPLAY PANEL - 5 mL Cup Label","PRINCIPAL DISPLAY PANEL - 10.15 mL Cup Label Delivers 10.15 mL NDC 39328-032-10 Acetaminophen Oral Solution USP 325 mg/10.15 mL Alcohol Free For Institutional Use Only See Insert Lot# xxxxxx Exp: yyyy/mm/dd Patrin Pharma Skokie, IL 60076 Rev 03.0324 PRINCIPAL DISPLAY PANEL - 10.15 mL Cup Label","PRINCIPAL DISPLAY PANEL - 20.3 mL Cup Label Delivers 20.3 mL NDC 39328-034-20 Acetaminophen Oral Solution USP 650 mg/20.3 mL Alcohol Free For Institutional Use Only See Insert Lot# xxxxxx Exp: yyyy/mm/dd Patrin Pharma Skokie, IL 60076 Rev 03.0324 PRINCIPAL DISPLAY PANEL - 20.3 mL Cup Label"],"pregnancy_or_breast_feeding":["If pregnant or breastfeeding, ask a health professional before use."],"purpose":["Purpose Pain reliever/fever reducer"],"questions":["Questions Or Comments? Call (800) 936-3088. You may also report serious side effects to this phone number."],"set_id":"52ae729b-2255-420c-8db8-cabdc2b74796","spl_product_data_elements":["Acetaminophen Solution Acetaminophen Acetaminophen ACETAMINOPHEN ANHYDROUS CITRIC ACID FD&C RED NO. 40 Glycerin POLYETHYLENE GLYCOL 400 WATER Saccharin sodium Sodium benzoate SODIUM CITRATE, UNSPECIFIED FORM Sorbitol Acetaminophen Solution Acetaminophen Acetaminophen ACETAMINOPHEN ANHYDROUS CITRIC ACID FD&C RED NO. 40 Glycerin POLYETHYLENE GLYCOL 400 WATER Saccharin sodium Sodium benzoate SODIUM CITRATE, UNSPECIFIED FORM Sorbitol Acetaminophen Solution Acetaminophen Acetaminophen ACETAMINOPHEN ANHYDROUS CITRIC ACID FD&C RED NO. 40 Glycerin POLYETHYLENE GLYCOL 400 WATER Saccharin sodium Sodium benzoate SODIUM CITRATE, UNSPECIFIED FORM Sorbitol"],"spl_unclassified_section":["Drug Facts","How Supplied A red, cherry flavored solution supplied in the following oral dosage cups: NDC 39328-031-05: 5 mL unit dose cup NDC 39328-031-50: Case contains 50 unit dose cups of 5 mL (39328-031-05). NDC 39328-031-99: Case contains 100 unit dose cups of 5 mL (39328-031-05). NDC 39328-032-10: 10.15 mL unit dose cup NDC 39328-032-50: Case contains 50 unit dose cups of 10.15 mL (39328-032-10). NDC 39328-032-99: Case contains 100 unit dose cups of 10.15 mL (39328-032-10). NDC 39328-034-20: 20.3 mL unit dose cup NDC 39328-034-50: Case contains 50 unit dose cups of 20.3 mL (39328-034-20). NDC 39328-034-99: Case contains 100 unit dose cups of 20.3 mL (39328-034-20).","Patrin Pharma Skokie, IL 60076 www.patrinpharma.com Rev 02.0424"],"spl_unclassified_section_table":["
NDC 39328-031-05:5 mL unit dose cup
NDC 39328-031-50:Case contains 50 unit dose cups of 5 mL (39328-031-05).
NDC 39328-031-99:Case contains 100 unit dose cups of 5 mL (39328-031-05).
","
NDC 39328-032-10:10.15 mL unit dose cup
NDC 39328-032-50:Case contains 50 unit dose cups of 10.15 mL (39328-032-10).
NDC 39328-032-99:Case contains 100 unit dose cups of 10.15 mL (39328-032-10).
","
NDC 39328-034-20:20.3 mL unit dose cup
NDC 39328-034-50:Case contains 50 unit dose cups of 20.3 mL (39328-034-20).
NDC 39328-034-99:Case contains 100 unit dose cups of 20.3 mL (39328-034-20).
"],"stop_use":["Stop use and ask a doctor if symptoms do not improve new symptoms occur pain or fever persists or gets worse redness or swelling is present"],"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 Do not use if foil on cup is missing or torn"],"version":"1","warnings":["Warnings Liver warning This product contains acetaminophen . Severe liver damage may occur if: an adult takes more than 6 doses in 24 hours, or greater than 4000 mg of acetaminophen, the maximum daily amount a child takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen taken with 3 or more alcoholic drinks every day while using this product Allergy 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 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 his product Ask a doctor before use if you have liver disease. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. Stop use and ask a doctor if symptoms do not improve new symptoms occur pain or fever persists or gets worse redness or swelling is present If pregnant or breastfeeding, 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."]}