{"active_ingredient":["Active Ingredients (in each 5 mL) Acetaminophen 160 mg"],"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 3 days for fever unless directed by a doctor for more that 10 days for pain unless directed by a doctor if you are allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin."],"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 excdeed 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 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 excdeed 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 under 2 years of ageconsult a doctor
"],"effective_time":"20241203","id":"28655b75-0302-94a1-e063-6394a90ae1dc","inactive_ingredient":["INACTIVE INGREDIENTS Citric acid, grape flavor, methylparaben, monoammonium glycyrrhizinate, potassium citrate, propylene glycol, propylparaben, purified water, sorbitol, sucralose"],"indications_and_usage":["USES Temporarily relieves minor aches and pains due to: headaches backaches toothaches muscular aches minor pain of arthritis the common cold premenstrual and menstrual cramps sore throat flu Temporarily reduces fever"],"keep_out_of_reach_of_children":["Keep out of reach of children. KEEP OUT OF REACH OF CHILDREN."],"openfda":{},"other_safety_information":["OTHER INFORMATION store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. keep tightly closed protect from light tamper evident: DO NOT use if foil on cup is missing or torn a clear, grape flavored solution supplied in the following oral dosage forms: NDC 81033-002-05: 5 mL (160mg) unit dose cup NDC 81033-002-55: Case contains 100 unit dose cups of 5 mL (81033-002-05); packaged in a carton of 50 unit dose cups each. NDC 81033-002-10: 10.15mL (325mg) unit dose cup NDC 81033-002-54: Case contains 100 unit dose cups of 10.15 mL (81033-002-10); packaged in a carton of 50 unit dose cups each. NDC 81033-002-20: 20.3 mL (650mg) unit dose cup NDC 81033-002-53: Case contains 100 unit dose cups of 20.3 mL (81033-002-20); packaged in a carton of 50 unit dose cups each."],"overdosage":["Overdose warning: 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 for children even if you do not notice any signs or symptoms."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 81033-002-05 Acetaminophen Oral Solution 160mg/5mL Delivers160mg/5mL Store at 68° - 77° F LOT EXP PKG by Kesin Pharma Oldsmar, FL Alcohol, Dye, Sugar Free For Institutional Use NDC 81033-002-10 Acetaminophen Oral Solution 160mg/5mL Delivers 325mg/10.15mL Store at 68° - 77° F LOT EXP PKG by Kesin Pharma Oldsmar, FL Alcohol, Dye, Sugar Free For Institutional Use NDC 81033-002-20 Acetaminophen Oral Solution 160mg/5mL Delivers 650mg/20.15mL Store at 68° - 77° F LOT EXP PKG by Kesin Pharma Oldsmar, FL Alcohol, Dye, Sugar Free For Institutional Use 5mL container label 10.15mL container label 20.3mL container label"],"pregnancy_or_breast_feeding":["If Pregnant or breast-feedinging If pregnant or breast-feeding, ask a health professional before use."],"purpose":["PURPOSE Pain reliever/fever reducer"],"questions":["QUESTIONS OR COMMENTS? Call Kesin Pharma at 1-833-537-4679. You may also report serious side effects to this phone number. Packaged by: Kesin Pharma Oldsmar, FL 34677 Effective: 08/2024 Revision 01 Kesin Pharma Logo"],"set_id":"c5b3c78c-9148-bf69-e053-2995a90aba65","spl_product_data_elements":["Acetaminophen Acetaminophen ACETAMINOPHEN ACETAMINOPHEN ANHYDROUS CITRIC ACID METHYLPARABEN PROPYLPARABEN PROPYLENE GLYCOL SORBITOL AMMONIUM GLYCYRRHIZATE POTASSIUM CITRATE WATER SUCRALOSE"],"spl_unclassified_section":["ACETAMINOPHEN Oral Solution 160mg per 5mL ACETAMINOPHEN Oral Solution 160mg per 5mL"],"stop_use":["Stop use and ask a doctor if Stop use and ask a doctor if symptoms do not improve new symptoms occur pain gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days redness or swelling is present These could be signs of a serious condition."],"version":"6","warnings":["WARNINGS Liver warning: This product contains acetaminophen. Severe liver damage may occur if: adult takes more than more than 6 doses in 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 everyday while using this product Ask a doctor before use if the user has liver disease. 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, persistent for more than 2 days, or is accompanied or followed by a fever, headache, nausea, rash, or vomiting, consult a physician 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 3 days for fever unless directed by a doctor for more that 10 days for pain unless directed by a doctor if you are allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin. Stop use and ask a doctor if Stop use and ask a doctor if symptoms do not improve new symptoms occur pain gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days redness or swelling is present These could be signs of a serious condition. If Pregnant or breast-feedinging If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. KEEP OUT OF REACH OF CHILDREN. Overdose warning: 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 for children even if you do not notice any signs or symptoms."]}