{"active_ingredient":["Active ingredient (in each 5mL) Acetaminophen 160 mg"],"ask_doctor":["Ask a doctor before use if your child has liver disease"],"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 find right dose on chart. If possible, use weight to dose; otherwise, use age give dose every 4 hours while symptoms last do not give more than 5 doses in 24 hours use enclosed dosing cup only. Do not use with any other device. mL = milliliter Weight Age Dose 72 - 95 lbs 11 years 15mL 60 - 71 lbs 9 - 10 years 12.5mL 48 - 59 lbs 6 - 8 years 10mL 36 - 47 lbs 4 - 5 years 7.5mL 24 - 35 lbs 2 - 3 years 5mL under 24 lbs under 2 years ask a doctor"],"dosage_and_administration_table":["<table width=\"80%\"> <col width=\"25%\" align=\"left\" valign=\"top\"/> <col width=\"25%\" align=\"left\" valign=\"top\"/> <col width=\"50%\" align=\"left\" valign=\"top\"/> <thead> <tr styleCode=\"Botrule\"> <th styleCode=\"Rrule Lrule\">Weight</th> <th styleCode=\"Rrule\">Age</th> <th styleCode=\"Rrule\">Dose</th> </tr> </thead> <tbody> <tr styleCode=\"Botrule\"> <td styleCode=\"Rrule Lrule\">72 - 95 lbs</td> <td styleCode=\"Rrule\">11 years</td> <td styleCode=\"Rrule\">15mL</td> </tr> <tr styleCode=\"Botrule\"> <td styleCode=\"Rrule Lrule\">60 - 71 lbs</td> <td styleCode=\"Rrule\">9 - 10 years</td> <td styleCode=\"Rrule\">12.5mL</td> </tr> <tr styleCode=\"Botrule\"> <td styleCode=\"Rrule Lrule\">48 - 59 lbs</td> <td styleCode=\"Rrule\">6 - 8 years</td> <td styleCode=\"Rrule\">10mL</td> </tr> <tr styleCode=\"Botrule\"> <td styleCode=\"Rrule Lrule\">36 - 47 lbs</td> <td styleCode=\"Rrule\">4 - 5 years</td> <td styleCode=\"Rrule\">7.5mL</td> </tr> <tr styleCode=\"Botrule\"> <td styleCode=\"Rrule Lrule\">24 - 35 lbs</td> <td styleCode=\"Rrule\">2 - 3 years</td> <td styleCode=\"Rrule\">5mL</td> </tr> <tr> <td styleCode=\"Rrule Lrule\">under 24 lbs</td> <td styleCode=\"Rrule\">under 2 years</td> <td styleCode=\"Rrule\">ask a doctor</td> </tr> </tbody> </table>"],"effective_time":"20190925","id":"9364a162-b5c4-7e06-e053-2995a90a3257","inactive_ingredient":["Inactive ingredients artificial flavor, citric acid anhydrous, D&C Red #33, FD&C Red #40, glycerin, polyethylene glycol 1450, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol."],"indications_and_usage":["Uses temporarily reduces fever and relieves minor aches and pains caused by 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 - 118 mL Bottle Label Rugby ® NDC 0536-0122-97 RELIEVES CHILDREN'S Pain &Fever ACETAMINOPHEN ORAL SOLUTION CHERRY FLAVORED SUGAR FREE Aspirin & Alcohol Free 4 fl oz (118 mL) 160mg per 5mL PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label"],"purpose":["Purpose Pain reliever-Fever reducer"],"questions":["Questions or comments? 1-800-645-2158"],"set_id":"465365ab-7262-4ad0-8ae0-481a2d429113","spl_product_data_elements":["Rugby Acetaminophen Acetaminophen GLYCERIN BENZOIC ACID SORBITOL SODIUM BENZOATE ANHYDROUS CITRIC ACID FD&C RED NO. 40 WATER SUCROSE PROPYLENE GLYCOL CHERRY POLYETHYLENE GLYCOL 1450 D&C RED NO. 33 ACETAMINOPHEN ACETAMINOPHEN"],"spl_unclassified_section":["Drug Facts","Distributed by: Rugby Laboratories 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152"],"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 appear redness or swelling is present. These could be signs of a serious condition."],"storage_and_handling":["Other information each 5 mL contains: sodium 1 mg store at 20 - 25°C (68 - 77°F)"],"version":"4","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. 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 or pharmacist before use if your child 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 appear 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 case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms."],"when_using":["When using this product, do not exceed recommended dose (see overdose warning )"]}