{"active_ingredient":["Active ingredients (in each 5 mL = 1 teaspoon) Purpose Acetaminophen 160 mg Pain reliever/fever reducer Diphenhydramine HCl 12.5 mg Antihistamine Phenylephrine HCl 2.5 mg Nasal decongestant"],"active_ingredient_table":["<table width=\"70%\"> <col width=\"65%\" align=\"left\" valign=\"top\"/> <col width=\"35%\" align=\"right\" valign=\"top\"/> <thead> <tr> <th> <content styleCode=\"italics\">Active ingredients (in each 5 mL = 1 teaspoon)</content> </th> <th> <content styleCode=\"italics\">Purpose</content> </th> </tr> </thead> <tbody> <tr> <td>Acetaminophen 160 mg</td> <td>Pain reliever/fever reducer</td> </tr> <tr> <td>Diphenhydramine HCl 12.5 mg</td> <td>Antihistamine</td> </tr> <tr> <td>Phenylephrine HCl 2.5 mg</td> <td>Nasal decongestant</td> </tr> </tbody> </table>"],"ask_doctor":["Ask a doctor before use if your child has liver disease heart disease high blood pressure thyroid disease diabetes a breathing problem such as chronic bronchitis glaucoma"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin taking sedatives or tranquilizers"],"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. to make a child sleepy with any other product containing diphenhydramine, even one used on the skin in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. if your child has ever had an allergic reaction to this product or any of its ingredients"],"dosage_and_administration":["Directions this product does not contain directions or complete warnings for adult use. do not give more than directed (see overdose warning ) shake well before using find right dose on chart below. If possible, use weight to dose; otherwise, use age. use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. if needed, repeat dose every 4 hours do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (tsp or mL) under 36 under 4 years do not use 36-47 4 to 5 years do not use unless directed by a doctor 48-95 6 to 11 years 2 tsp or 10 mL Attention use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device."],"dosage_and_administration_table":["<table width=\"75%\"> <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\">Weight (lb)</th> <th styleCode=\"Lrule\">Age (yr)</th> <th styleCode=\"Lrule Rrule\">Dose (tsp or mL)</th> </tr> </thead> <tbody> <tr styleCode=\"Botrule\"> <td styleCode=\"Lrule Rrule\">under 36</td> <td styleCode=\"Rrule\">under 4 years</td> <td styleCode=\"Rrule\">do not use</td> </tr> <tr styleCode=\"Botrule\"> <td styleCode=\"Lrule Rrule\">36-47</td> <td styleCode=\"Rrule\">4 to 5 years</td> <td styleCode=\"Rrule\">do not use unless directed by a doctor</td> </tr> <tr> <td styleCode=\"Lrule Rrule\">48-95</td> <td styleCode=\"Rrule\">6 to 11 years</td> <td styleCode=\"Rrule\">2 tsp or 10 mL</td> </tr> </tbody> </table>"],"effective_time":"20121227","id":"59b7b7c6-5a48-461e-9cac-b0032434267f","inactive_ingredient":["Inactive ingredients anhydrous citric acid, D&C red #33, FD&C red #40, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, sucralose, sucrose, xanthan gum"],"indications_and_usage":["Uses for the temporary relief of the following cold and hay fever or other upper respiratory allergy symptoms: minor aches and pains headache sore throat itchy, watery eyes itching of the nose or throat sneezing runny nose nasal congestion stuffy nose temporarily reduces fever"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL See New Warnings Information NDC 50580-390-04 Children's TYLENOL ® Plus COLD & ALLERGY Fever & Sore Throat Acetaminophen Itchy, Watery Eyes, Sneezing & Runny Nose Diphenhydramine HCl Stuffy Nose Phenylephrine HCl BUBBLE GUM FLAVOR 4 FL OZ (120mL) ORAL SUSPENSION Principal Display Panel"],"purpose":["Active ingredients (in each 5 mL = 1 teaspoon) Purpose Acetaminophen 160 mg Pain reliever/fever reducer Diphenhydramine HCl 12.5 mg Antihistamine Phenylephrine HCl 2.5 mg Nasal decongestant"],"purpose_table":["<table width=\"70%\"> <col width=\"65%\" align=\"left\" valign=\"top\"/> <col width=\"35%\" align=\"right\" valign=\"top\"/> <thead> <tr> <th> <content styleCode=\"italics\">Active ingredients (in each 5 mL = 1 teaspoon)</content> </th> <th> <content styleCode=\"italics\">Purpose</content> </th> </tr> </thead> <tbody> <tr> <td>Acetaminophen 160 mg</td> <td>Pain reliever/fever reducer</td> </tr> <tr> <td>Diphenhydramine HCl 12.5 mg</td> <td>Antihistamine</td> </tr> <tr> <td>Phenylephrine HCl 2.5 mg</td> <td>Nasal decongestant</td> </tr> </tbody> </table>"],"questions":["Questions or comments? call 1-877-895-3665"],"set_id":"7523ac1e-c056-4784-ba5f-c4f53c8873a3","spl_product_data_elements":["Childrens Tylenol Plus Cold and Allergy Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride Acetaminophen acetaminophen Diphenhydramine Hydrochloride Diphenhydramine Phenylephrine Hydrochloride phenylephrine anhydrous citric acid carboxymethylcellulose sodium D&C Red NO. 33 FD&C Red NO. 40 glycerin cellulose, microcrystalline water sodium benzoate sorbitol sucralose sucrose xanthan gum"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if nervousness, dizziness or sleeplessness occur pain or nasal congestion gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition"],"storage_and_handling":["Other information store between 20-25°C (68-77°F) do not use if bottle wrap, or foil inner seal imprinted \"Safety Seal®\" is broken or missing see bottom panel for lot number and expiration date"],"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. to make a child sleepy with any other product containing diphenhydramine, even one used on the skin in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. if your child has ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if your child has liver disease heart disease high blood pressure thyroid disease diabetes a breathing problem such as chronic bronchitis glaucoma Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product do not exceed recommended dose (see overdose warning ) excitability may occur, especially in children marked drowsiness may occur sedatives and tranquilizers may increase drowsiness Stop use and ask a doctor if nervousness, dizziness or sleeplessness occur pain or nasal congestion gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur 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 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 ) excitability may occur, especially in children marked drowsiness may occur sedatives and tranquilizers may increase drowsiness"]}