{"active_ingredient":["Active Ingredients (in each 5 mL) Acetaminophen 160 mg Dextromethorphan HBr 5 mg"],"ask_doctor":["Ask a doctor before use if your child has • liver disease • persistent or chronic cough such as occurs with asthma • cough that occurs with too much phlegm (mucus)"],"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. • 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 • mL = milliliter • find right dose on chart below. If possible, use weight to dose; otherwise, use age. • remove the child protective cap and squeeze your child’s dose into the dosing cup • repeat dose every 4 hours, while symptoms last • do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (mL) under 36 under 4 years do not use 36-47 4 to 5 years 5 mL 48-95 6 to 11 years 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":["
Weight (lb)Age (yr)Dose (mL)
under 36under 4 yearsdo not use
36-474 to 5 years5 mL
48-956 to 11 years10 mL
"],"effective_time":"20221006","id":"07489986-5427-48fc-b4ce-4c2ac83fac04","inactive_ingredient":["Inactive Ingredients anhydrous citric acid, calcium sulfate, carrageenan, D&C red #33, edetate disodium, FD&C red #40, flavor, glycerin, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, tribasic sodium phosphate, xanthan gum"],"indications_and_usage":["Uses • temporarily relieves the following cold/flu symptoms: • minor aches and pains • headache • sore throat • cough • temporarily reduces fever"],"keep_out_of_reach_of_children":["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 even if you do not notice any signs or symptoms."],"openfda":{},"package_label_principal_display_panel":["Package/Label Principal Display Panel COMPARE TO CHILDREN’S TYLENOL® COLD + COUGH + SORE THROAT ORAL SUSPENSION ACTIVE INGREDIENTS children’s Cold, Cough & Sore Throat ORAL SUSPENSION PAIN RELIEVER – FEVER REDUCER – ACETAMINOPHEN COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr RELIEVES: Fever Sore Throat Cough OUR PHARMACISTS RECOMMEND Ages 4 to 11 Years BUBBLE GUM FLAVOR 4 FL OZ (118 mL) Children's Cold Cough and Sore Throat Carton"],"purpose":["Purposes Pain reliever/fever reducer Cough suppressant"],"questions":["Questions or comments? 1-888-423-0139"],"set_id":"467a8f31-c0bc-4a87-a0f0-dcc50c9a7c2f","spl_product_data_elements":["Topcare childrens cold cough and sore throat acetaminophen, dextromethorphan Hydrobromide ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ANHYDROUS CITRIC ACID CALCIUM SULFATE, UNSPECIFIED FORM CARRAGEENAN D&C RED NO. 33 EDETATE DISODIUM FD&C RED NO. 40 GLYCERIN POLYSORBATE 80 WATER SODIUM BENZOATE SORBITOL SUCROSE SODIUM PHOSPHATE, TRIBASIC XANTHAN GUM"],"stop_use":["Stop use and ask a doctor if • pain or cough 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 • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition."],"storage_and_handling":["Other information • each 5 mL contains: sodium 3 mg • store at 20-25 ° C (68-77 ° F) • do not use if printed neckband is broken or missing"],"version":"3","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 dosage (see overdose warning)"]}