{"active_ingredient":["Active ingredient Purpose (in each 5 mL = 1 teaspoon) Acetaminophen 160 mg"],"ask_doctor":["Ask a doctor before use if your child has liver disease. Ask a doctor before use if your child is under 6 mos. or 12 lbs. OR over 12 yrs. or 95 lbs.","Ask a doctor before use if your child is under 6 mos. or 12 lbs. OR over 12 yrs. or 95 lbs."],"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 nonprescription). 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. shake well before using if needed, repeat dose every 4 hours do not use more than 5 times in 24 hours when weight is known: use the rotating bottle label to find the child's weight and read the correct dose. This is the most accurate dose. when weight is unknown: use the age chart on the rotating label. use only enclosed dosing syringe and adapter to dose this product. Do not use any other dosing device Age (yr) Dose (mL or tsp) under 6 mos. ask a doctor 6 mos. to under 2 2.5 mL or ½ tsp. 2 to under 4 5 mL or 1 tsp. 4 to under 6 7.5 mL or 1½ tsp. 6 to under 9 10 mL or 2 tsp. 9 to under 11 12.5 mL or 2½ tsp. 11 to under 12 15 mL or 3 tsp. or as directed by a doctor tsp. = teaspoon mL = milliliter"],"dosage_and_administration_table":["<table width=\"60%\"> <col width=\"50%\" align=\"center\" valign=\"middle\"/> <col width=\"50%\" align=\"center\" valign=\"middle\"/> <thead> <tr> <th styleCode=\"Lrule Rrule\">Age (yr)</th> <th styleCode=\"Rrule\">Dose (mL or tsp)</th> </tr> </thead> <tbody> <tr styleCode=\"Botrule\"> <td styleCode=\"Lrule Rrule\">under 6 mos.</td> <td styleCode=\"Rrule\">ask a doctor</td> </tr> <tr styleCode=\"Botrule\"> <td styleCode=\"Lrule Rrule\">6 mos. to under 2</td> <td styleCode=\"Rrule\">2.5 mL or &#xBD; tsp.</td> </tr> <tr styleCode=\"Botrule\"> <td styleCode=\"Lrule Rrule\">2 to under 4</td> <td styleCode=\"Rrule\">5 mL or 1 tsp.</td> </tr> <tr styleCode=\"Botrule\"> <td styleCode=\"Lrule Rrule\">4 to under 6</td> <td styleCode=\"Rrule\">7.5 mL or 1&#xBD; tsp.</td> </tr> <tr styleCode=\"Botrule\"> <td styleCode=\"Lrule Rrule\">6 to under 9</td> <td styleCode=\"Rrule\">10 mL or 2 tsp.</td> </tr> <tr styleCode=\"Botrule\"> <td styleCode=\"Lrule Rrule\">9 to under 11</td> <td styleCode=\"Rrule\">12.5 mL or 2&#xBD; tsp.</td> </tr> <tr styleCode=\"Botrule\"> <td styleCode=\"Lrule Rrule\">11 to under 12</td> <td styleCode=\"Rrule\">15 mL or 3 tsp.</td> </tr> <tr styleCode=\"Botrule\"> <td styleCode=\"Lrule Rrule\" colspan=\"2\">or as directed by a doctor</td> </tr> <tr styleCode=\"Botrule\"> <td align=\"left\">tsp. = teaspoon</td> <td align=\"right\">mL = milliliter</td> </tr> </tbody> </table>"],"effective_time":"20111026","id":"c96c5d9b-5566-4135-9438-0032c4e9b5a0","inactive_ingredient":["Inactive ingredients artificial flavor, citric acid anhydrous USP, D&C Red #33, FD&C Red #40, glycerin USP, non-crystalline sorbitol 70% USP, polyethylene glycol NF, propylene glycol, purified water, sodium benzoate, sodium saccharin."],"indications_and_usage":["Uses Temporarily relieves minor aches and pains due to: the common cold flu headache sore throat toothache Temporarily reduces fever"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{},"overdosage":["Overdose warning Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Prompt medical attention is critical, even if you do not notice any signs or symptoms."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton Children's ACCU DIAL ® Acetaminophen Oral Solution Pain Reliever / Fever Reducer For ages 6 mos. to under 12 or 12-95 lbs. Alcohol Free • Aspirin Free • Ibuprofen Free Compares to the active ingredient in Children's Tylenol ® Oral Solution. ROTATING LABEL FOR WEIGHT-BASED DOSING Cherry Flavor 4 FL. OZ. (120 mL) 80 mg per 1/2 teaspoon (160 mg per 5 mL) NDC 45014-130-04 PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton"],"purpose":["Purpose Pain reliever/fever reducer"],"questions":["Questions? 877-434-2036"],"set_id":"a6c6a3f7-0295-4715-9bf8-cfecef7b13e2","spl_product_data_elements":["Acetaminophen Acetaminophen Acetaminophen acetaminophen Glycerin Sorbitol Sodium Benzoate Anhydrous citric acid FD&C Red no. 40 Water saccharin sodium Propylene glycol Prunus Serotina Bark POLYETHYLENE GLYCOL 1450 D&C RED NO. 33"],"spl_unclassified_section":["Drug Facts","DISTRIBUTED BY ACCUDIAL PHARMACEUTICAL, INC. Palm Beach Gardens, FL 33408"],"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 teaspoon contains: sodium 2 mg store between 20°-25°C (68°-77°F) tamper evident: do not use if foil seal over the mouth of the bottle is torn, broken, or missing."],"version":"1","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. 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 is allergic to acetaminophen or any of the inactive ingredients in this product. Ask a doctor before use if your child has liver disease. Ask a doctor before use if your child is under 6 mos. or 12 lbs. OR over 12 yrs. or 95 lbs. Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin. When using this product Do not use more than directed. 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 Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Prompt medical attention is critical, even if you do not notice any signs or symptoms."],"when_using":["When using this product Do not use more than directed."]}