{"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 Use as directed per healthcare professional. do not take more than directed (see overdose warning ) shake well before using find the right dose on chart below. If possible, use weight to dose; otherwise, use age. repeat dose every 4 hours while symptoms last do not take more than 5 times in 24 hours Weight (lb) Age (yr) Dose (mL) or as directed by a doctor 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) or as directed by a doctor
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":"20250818","how_supplied":["How Supplied grape flavored suspension supplied in the following oral dosage forms: NDC 0121-0941-05: 5 mL unit dose cup, in a tray of ten cups. NDC 0121-1882-11: 10.15 mL unit dose cup, in a tray of ten cups. NDC 0121-2823-21: 20.3 mL unit dose cup, in a tray of ten cups."],"id":"bbd6f65a-a6ec-4c17-935c-ed743c45e2c8","inactive_ingredient":["Inactive ingredients acesulfame potassium, butylparaben, citric acid anhydrous, flavoring, glycerin, high fructose corn syrup, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, 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":{"application_number":["M013"],"brand_name":["Acetaminophen"],"generic_name":["ACETAMINOPHEN"],"is_original_packager":[true],"manufacturer_name":["PAI Holdings, LLC dba PAI Pharma"],"package_ndc":["0121-0941-05","0121-0941-94","0121-0941-00","0121-1882-11","0121-1882-94","0121-1882-00","0121-2823-21","0121-2823-94"],"product_ndc":["0121-0941","0121-1882","0121-2823"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["307668"],"spl_id":["bbd6f65a-a6ec-4c17-935c-ed743c45e2c8"],"spl_set_id":["caf5daea-409e-5dd2-e053-2995a90acb12"],"substance_name":["ACETAMINOPHEN"],"unii":["362O9ITL9D"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 5 mL Cup Label NDC 0121-0941-05 ACETAMINOPHEN ORAL SUSPENSION 160 mg per 5 mL DYE FREE/GRAPE FLAVOR Ibuprofen Free/Alcohol Free/Aspirin Free Pain Reliever-Fever Reducer SHAKE WELL BEFORE USING Package Not Child-Resistant Pharmaceutical Associates, Inc. Greenville, SC 29605 PRINCIPAL DISPLAY PANEL - 5 mL Cup Label","PRINCIPAL DISPLAY PANEL - 10.15 mL Cup Label NDC 0121-1882-11 ACETAMINOPHEN ORAL SUSPENSION 325 mg per 10.15 mL DYE FREE/GRAPE FLAVOR Ibuprofen Free/Alcohol Free/Aspirin Free Pain Reliever-Fever Reducer SHAKE WELL BEFORE USING Package Not Child-Resistant Pharmaceutical Associates, Inc. Greenville, SC 29605 PRINCIPAL DISPLAY PANEL - 5 mL Cup Label","PRINCIPAL DISPLAY PANEL - 20.3 mL Cup Label NDC 0121-2823-21 ACETAMINOPHEN ORAL SUSPENSION 650 mg per 20.3 mL DYE FREE/GRAPE FLAVOR Ibuprofen Free/Alcohol Free/Aspirin Free Pain Reliever-Fever Reducer SHAKE WELL BEFORE USING Package Not Child-Resistant Pharmaceutical Associates, Inc. Greenville, SC 29605 PRINCIPAL DISPLAY PANEL - 5 mL Cup Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Pain reliever/fever reducer"],"questions":["Call 1-800-845-8210."],"set_id":"caf5daea-409e-5dd2-e053-2995a90acb12","spl_product_data_elements":["Acetaminophen Acetaminophen ACETAMINOPHEN ACETAMINOPHEN ACESULFAME POTASSIUM BUTYLPARABEN ANHYDROUS CITRIC ACID GLYCERIN HIGH FRUCTOSE CORN SYRUP POLYSORBATE 80 PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SOLUTION XANTHAN GUM to Off-white Acetaminophen Acetaminophen ACETAMINOPHEN ACETAMINOPHEN ACESULFAME POTASSIUM BUTYLPARABEN ANHYDROUS CITRIC ACID GLYCERIN HIGH FRUCTOSE CORN SYRUP POLYSORBATE 80 PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SOLUTION XANTHAN GUM to Off-white Acetaminophen Acetaminophen ACETAMINOPHEN ACETAMINOPHEN ACESULFAME POTASSIUM BUTYLPARABEN ANHYDROUS CITRIC ACID GLYCERIN HIGH FRUCTOSE CORN SYRUP POLYSORBATE 80 PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SOLUTION XANTHAN GUM to Off-white"],"spl_unclassified_section":["Drug Facts","Alcohol Free, Aspirin Free, Gluten Free, Ibuprofen Free","MANUFACTURED BY Pharmaceutical Associates, Inc. Greenville, SC 29860 www.paipharma.com"],"stop_use":["Stop use and ask a doctor if pain gets worse or lasts more than 10 days (for adults) or 5 days (for children) 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. do not give this product to children for the pain of arthritis unless directed by a doctor"],"storage_and_handling":["Other information each 5 mL contains: sodium: 2 mg Store at 20° to 25°C (68° to 77°F)"],"version":"5","warnings":["Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if adult takes more than 4,000 mg of acetaminophen in 24 hours 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. 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 10 days (for adults) or 5 days (for children) 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. do not give this product to children for the pain of arthritis unless directed by a doctor If pregnant or breast-feeding, ask a health professional before use. 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 )"]}