"],"ask_doctor":["Ask a doctor before use if your child has liver disease a breathing problem such as chronic bronchitis glaucoma 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 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 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 the 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 do not use unless directed by a doctor 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 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
10 mL
"],"effective_time":"20251111","id":"434f84ba-ba81-a4e6-e063-6394a90ae042","inactive_ingredient":["Inactive ingredients citric acid, carboxymethylcellulose sodium, D&C Red No. 33, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavors, glycerin, microcrystalline cellulose, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum"],"indications_and_usage":["Uses temporarily relieves the following cold/flu symptoms: minor aches and pains headache sore throat sneezing and runny nose cough temporarily reduces fever"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{"application_number":["M012"],"brand_name":["TOPCARE Childrens Cold and Cough and Runny Nose"],"generic_name":["ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE"],"is_original_packager":[true],"manufacturer_name":["Topco Associates, LLC"],"package_ndc":["76162-792-04"],"product_ndc":["76162-792"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1086750"],"spl_id":["434f84ba-ba81-a4e6-e063-6394a90ae042"],"spl_set_id":["8931d4ca-c599-49be-87e1-8c0598f38b77"],"substance_name":["CHLORPHENIRAMINE MALEATE","DEXTROMETHORPHAN HYDROBROMIDE","ACETAMINOPHEN"],"unii":["V1Q0O9OJ9Z","9D2RTI9KYH","362O9ITL9D"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL COMPARE TO THE ACTIVE INGREDIENTS IN CHILDREN’S TYLENOL® COLD + COUGH + RUNNY NOSE* NDC 76162-792-04 Children's Cold & Cough & Runny Nose Relief ORAL SUSPENSION ACETAMINOPHEN - PAIN RELIEVER-FEVER REDUCER CHLORPHENIRAMINE MALEATE - ANTIHISTAMINE DEXTROMETHORPHAN HBR - COUGH SUPPRESSANT RELIEVES Fever Sore Throat Sneezing Runny Nose Cough GRAPE FLAVOR NATURALLY AND ARTIFICIALLY FLAVORED Ages 6-11 Years 4 FL OZ (120 mL) IMPORTANT: Keep this carton for future reference on full labeling. TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAT UNDER CAP IS TORN OR MISSING. Distributed by: *This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Children’s Tylenol ® Cold + Cough + Runny Nose. TOPCO Childrens Cold plus Cough Plus Runny Nose Relief"],"package_label_principal_display_panel_table":["
IMPORTANT: Keep this carton for future reference on full labeling.
"],"questions":["Questions or comments? 1-866-467-2748"],"set_id":"8931d4ca-c599-49be-87e1-8c0598f38b77","spl_product_data_elements":["TOPCARE Childrens Cold and Cough and Runny Nose Acetaminophen, Chlorpheniramine Maleate, and Dextromethorphan Hydrobromide CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ANHYDROUS CITRIC ACID CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED D&C RED NO. 33 EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN MICROCRYSTALLINE CELLULOSE PROPYL GALLATE PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SUCROSE XANTHAN GUM ACETAMINOPHEN ACETAMINOPHEN"],"spl_unclassified_section":["Drug Facts"],"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 room temperature TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING"],"version":"2","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. to make a child sleepy 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 a breathing problem such as chronic bronchitis glaucoma persistent or chronic cough such as occurs with asthma cough that occurs with too much phlegm (mucus) 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 ) marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children 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. 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 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 ) marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children"]}