{"active_ingredient":["Active ingredient (in each 5 mL) Acetaminophen 160 mg"],"ask_doctor":["Ask a doctor before use if your child has liver disease. Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin"],"do_not_use":["Do not use with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if your child is allergic to acetaminophen or any of the inactive ingredients in this product"],"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 Attention: For Single-Dose Cups, the entire dose should be taken. 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 *or as directed by a doctor"],"effective_time":"20250204","id":"89d3db5b-5a3b-41d3-b2d1-223932ba25d1","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 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":["Dye Free Childrens Acetaminophen"],"generic_name":["ACETAMINOPHEN"],"is_original_packager":[true],"manufacturer_name":["PAI Holdings, LLC dba PAI Pharma"],"package_ndc":["0121-0966-05","0121-0966-94","0121-0966-00"],"product_ndc":["0121-0966"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["307668"],"spl_id":["89d3db5b-5a3b-41d3-b2d1-223932ba25d1"],"spl_set_id":["a69fca9d-c0a0-4321-bf03-5c8e99cc07cc"],"substance_name":["ACETAMINOPHEN"],"unii":["362O9ITL9D"]},"overdosage":["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 children even if you do not notice any sign or symptoms."],"package_label_principal_display_panel":["Principal Display Panel Delivers 5 mL NDC 0121-0966-05 DYE FREE/GRAPE FLAVOR Children's 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. SEE INSERT Children's Acetaminophen Oral Suspension"],"purpose":["Purpose Acetaminophen 160 mg.............................Pain reliever/fever reducer"],"questions":["Questions or Comments? Call 1-800-845-8210. MANUFACTURED BY: Pharmaceutical Associates, Inc. Greenville, SC 29605 www.paipharma.com R01/22"],"set_id":"a69fca9d-c0a0-4321-bf03-5c8e99cc07cc","spl_product_data_elements":["Dye Free Childrens Acetaminophen Acetaminophen ACETAMINOPHEN ACETAMINOPHEN MAGNESIUM ALUMINUM SILICATE ACESULFAME POTASSIUM BUTYLPARABEN ANHYDROUS CITRIC ACID HIGH FRUCTOSE CORN SYRUP POLYSORBATE 80 PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SOLUTION XANTHAN GUM to off-white appearance grape flavor"],"spl_unclassified_section":["Other information each 5 mL contains: sodium: 2 mg Store at 20° to 25°C (68° to 77°F) grape flavored suspension supplied in the following oral dosage form: NDC 0121-0966-05: 5 mL unit dose cup, in a tray of ten cups. NDC 0121-0966-94: Case contains 30 unit dose cups of 5 mL (0121-0966-05) packaged in 3 trays of 10 unit dose cups each. NDC 0121-0966-00: Case contains 100 unit dose cups of 5 mL (0121-0966-05) packaged in 10 trays of 10 unit dose cups each."],"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."],"version":"8","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes: • 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."],"when_using":["When using this product do not exceed recommended dose (see overdose warning)"]}