{"active_ingredient":["Active ingredient (in each 5 mL) 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 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 have ever had an allergic reaction to this product or any of its ingredients"],"dosage_and_administration":["Directions • this product does not contain directions or complete warnings for adult use • do not take more than directed (see overdose warning) • shake well before using • mL = milliliter • find right dose on chart below. If possible, use weight to dose; otherwise, use age. • repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (mL) * Under 24 Under 2 years ask a doctor 24-35 2-3 years 5 mL 36-47 4-5 years 7.5 mL 48-59 6-8 years 10 mL 60-71 9-10 years 12.5 mL 72-95 11 years 15 mL Over 96 adults and children 12 years and over 20 mL"],"dosage_and_administration_table":["
Weight (lb) Age (yr) Dose (mL) *
Under 24Under 2 yearsask a doctor
24-352-3 years5 mL
36-474-5 years7.5 mL
48-596-8 years10 mL
60-719-10 years12.5 mL
72-9511 years15 mL
Over 96adults and children 12 years and over20 mL
"],"effective_time":"20240507","id":"6106e932-093d-406c-ac3c-27a070ab36bd","inactive_ingredient":["Inactive ingredients acesulfame K, butylparaben, citric acid, flavoring, glycerin, high fructose corn syrup, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, veegum and xanthan gum."],"indications_and_usage":["Uses temporarily: reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 5 mL Cup Label Delivers 5 mL NDC 0121-0939-05 CHILDREN'S ACTAMINOPHEN ORAL SUSPENSION 160 mg per 5 mL DYE FREE Ibuprofen Free/Alcohol Free/Aspirin Free Pain Reliever-Fever Reducer SHAKE WELL BEFORE USING Package Not Child-Resistant Pharmaceutical Associates, Inc. Greenville, SC 29605 SEE INSERT PRINCIPAL DISPLAY PANEL - 5 mL Cup Label","PRINCIPAL DISPLAY PANEL - 10 mL Cup Label Delivers 10 mL NDC 0121-1878-10 CHILDREN'S ACTAMINOPHEN ORAL SUSPENSION 320 mg per 10 mL DYE FREE Ibuprofen Free/Alcohol Free/Aspirin Free Pain Reliever-Fever Reducer SHAKE WELL BEFORE USING Package Not Child-Resistant Pharmaceutical Associates, Inc. Greenville, SC 29605 SEE INSERT PRINCIPAL DISPLAY PANEL - 10 mL Cup Label"],"purpose":["Purpose Pain reliever/fever reducer"],"questions":["Call 1-800-845-8210."],"set_id":"b9bccbf8-f9c4-abe7-e053-2995a90a943e","spl_product_data_elements":["Childrens Acetaminophen Acetaminophen ACETAMINOPHEN ACETAMINOPHEN MAGNESIUM ALUMINUM SILICATE ACESULFAME POTASSIUM BUTYLPARABEN ANHYDROUS CITRIC ACID GLYCERIN HIGH FRUCTOSE CORN SYRUP POLYSORBATE 80 PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SOLUTION XANTHAN GUM clear, dye-free Childrens Acetaminophen Acetaminophen ACETAMINOPHEN ACETAMINOPHEN MAGNESIUM ALUMINUM SILICATE ACESULFAME POTASSIUM BUTYLPARABEN ANHYDROUS CITRIC ACID GLYCERIN HIGH FRUCTOSE CORN SYRUP POLYSORBATE 80 PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SOLUTION XANTHAN GUM clear, dye-free"],"spl_unclassified_section":["Drug Facts","Manfactured By Pharmaceutical Associates, Inc. Greenville, SC 29605 www.paipharma.com"],"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 • new symptoms occur • redness or swelling is present These could be signs of a serious condition."],"storage_and_handling":["Other information each 5 mL contains: sodium: 2 mg Store at 20° to 25°C (68° to 77°F) berry flavored suspension supplied in the following oral dosage forms: NDC 0121-0939-05: 5 mL unit dose cup, in a tray of ten cups. NDC 0121-1878-10: 10 mL unit dose cup, in a tray of ten cups."],"version":"8","warnings":["Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if • more than 5 doses in 24 hours, which is the maximum daily amount • with other drugs containing 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. if you have ever had an allergic reaction to this product or any of its ingredients 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 thinning drug warfarin When using this product do not exceed recommended dose (see overdose warning ) 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 • new symptoms occur • redness or swelling is present These could be signs of a serious condition. Keep out of reach of children. Overdose warning 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."],"when_using":["When using this product do not exceed recommended dose (see overdose warning )"]}