{"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 your child has 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":["<table width=\"60%\"><col width=\"33%\" align=\"center\" valign=\"middle\"/><col width=\"34%\" align=\"center\" valign=\"middle\"/><col width=\"33%\" align=\"center\" valign=\"middle\"/><thead><tr><th styleCode=\"Lrule Rrule\">Weight (lb)</th><th styleCode=\"Rrule\">Age (yr)</th><th styleCode=\"Rrule\">Dose (mL)<footnote>or as directed by a doctor</footnote></th></tr></thead><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">under 24</td><td styleCode=\"Rrule\">under 2 years</td><td styleCode=\"Rrule\">ask a doctor</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">24-35</td><td styleCode=\"Rrule\">2-3 years</td><td styleCode=\"Rrule\">5 mL</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">36-47</td><td styleCode=\"Rrule\">4-5 years</td><td styleCode=\"Rrule\">7.5 mL</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">48-59</td><td styleCode=\"Rrule\">6-8 years</td><td styleCode=\"Rrule\">10 mL</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">60-71</td><td styleCode=\"Rrule\">9-10 years</td><td styleCode=\"Rrule\">12.5 mL</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">72-95</td><td styleCode=\"Rrule\">11 years</td><td styleCode=\"Rrule\">15 mL</td></tr><tr><td styleCode=\"Lrule Rrule\">Over 96</td><td styleCode=\"Rrule\">Adults and children 12 years and over</td><td styleCode=\"Rrule\">20 mL</td></tr></tbody></table>"],"effective_time":"20250219","id":"c1901824-e0d1-4a91-83c5-fc2737cb32ea","inactive_ingredient":["Inactive ingredients anhydrous citric acid, calcium sulfate, carrageenan, D&C red #33, FD&C blue #1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, tribasic sodium phosphate"],"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"],"manufacturer_name":["Precision Dose, Inc."],"original_packager_product_ndc":["0113-0212"],"package_ndc":["68094-130-01","68094-130-58"],"product_ndc":["68094-130"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["307668"],"spl_id":["c1901824-e0d1-4a91-83c5-fc2737cb32ea"],"spl_set_id":["b16e5dcf-b290-4ff2-a150-4b875647ec9a"],"substance_name":["ACETAMINOPHEN"],"unii":["362O9ITL9D"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 2.5 mL Syringe Label ACETAMINOPHEN ORAL SUSPENSION 80 mg / 2.5 mL Delivers 2.5 mL Store at 20-25°C (68-77°F) Hospital Use Only • Alcohol Free Aspirin Free • Gluten Free • Ibuprofen Free For Oral Use Only Pkg: Precision Dose, Inc. S. Beloit, IL 61080 PRINCIPAL DISPLAY PANEL - 2.5 mL Syringe 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? 1-800-397-9228"],"set_id":"b16e5dcf-b290-4ff2-a150-4b875647ec9a","spl_product_data_elements":["Acetaminophen Acetaminophen Acetaminophen Acetaminophen ANHYDROUS CITRIC ACID BUTYLPARABEN CALCIUM SULFATE, UNSPECIFIED FORM CARRAGEENAN D&C RED NO. 33 FD&C BLUE NO. 1 GLYCERIN HIGH FRUCTOSE CORN SYRUP MICROCRYSTALLINE CELLULOSE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SODIUM PHOSPHATE, TRIBASIC viscous"],"spl_unclassified_section":["Grape Flavor 80 mg/2.5 mL 160 mg/5 mL 325 mg/10.15 mL 650 mg/20.3 mL For Hospital Use Only LI1650 Rev. 10/24 Drug Facts","Alcohol Free, Aspirin Free, Gluten Free, Ibuprofen Free","How Supplied NDC 68094-042-58 2.5 mL per unit dose ENFit syringe Fifty (50) syringes per shipper NDC 68094-038-58 5 mL per unit dose ENFit syringe Fifty (50) syringes per shipper NDC 68094-130-58 2.5 mL per unit dose syringe Fifty (50) syringes per shipper NDC 68094-231-58 5 mL per unit dose syringe Fifty (50) syringes per shipper NDC 68094-231-61 5 mL per unit dose cup One hundred (100) cups per shipper NDC 68094-231-62 5 mL per unit dose cup Thirty (30) cups per shipper NDC 68094-330-61 10.15 mL per unit dose cup One hundred (100) cups per shipper NDC 68094-330-62 10.15 mL per unit dose cup Thirty (30) cups per shipper NDC 68094-030-62 20.3 mL per unit dose cup Thirty (30) cups per shipper","Packaged By: Precision Dose, Inc. South Beloit, IL 61080 For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email druginfo@precisiondose.com LI1650 Rev. 10/24"],"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 pain of arthritis unless directed by a doctor"],"storage_and_handling":["Other information each 5 mL contains: sodium 3 mg store at 20-25°C (68-77°F)"],"version":"6","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 your child has 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 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 )"]}