{"active_ingredient":["Active ingredients (in each 5 mL) Purposes Acetaminophen 160 mg Pain reliever/fever reducer Dextromethorphan HBr 5 mg Cough suppressant"],"active_ingredient_table":["
Active ingredients (in each 5 mL)Purposes
Acetaminophen 160 mgPain reliever/fever reducer
Dextromethorphan HBr 5 mgCough suppressant
"],"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 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 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":"20260814","id":"1fec45d1-9c35-4e8e-b0dc-58bacda9abc6","inactive_ingredient":["Inactive ingredients carboxymethylcellulose sodium, anhydrous citric acid, D&C red no. 33, disodium edetate, FD&C red no. 40, flavors, glycerin, microcrystalline cellulose, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose, 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."],"openfda":{"application_number":["M012"],"brand_name":["CVS Childrens COLD PLUS COUGH PLUS SORE THROAT"],"generic_name":["ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE"],"is_original_packager":[true],"manufacturer_name":["CVS PHARMACY"],"package_ndc":["51316-650-04"],"product_ndc":["51316-650"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1370113"],"spl_id":["1fec45d1-9c35-4e8e-b0dc-58bacda9abc6"],"spl_set_id":["27820bce-6638-4f17-ac66-62b02b76bec3"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE"],"unii":["362O9ITL9D","9D2RTI9KYH"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Compare to the active ingredients in Children’s Tylenol® Cold + Cough + Sore Throat* NDC 51316-650-04 Children's Cold + Cough + Sore Throat Relief Acetaminophen, Pain Reliever-Fever Reducer Dextromethorphan HBr, Cough Suppressant Oral Suspension Ages 4-11 Years • Fever • Sore Throat • Cough Ibuprofen free, aspirin free, No added alcohol Bubblegum Flavor Naturally and Artificially Flavored 4 FL OZ (120 mL) *This product is not manufactured or distributed by Johnson & Johnson Consumer Inc, distributor of Children’s Tylenol® Cold + Cough + Sore Throat. TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAPS IS TORN OR MISSING. CVS Children's Cold + Cough + Sore Throat Relief 4 FL OZ 120 mL"],"purpose":["Active ingredients (in each 5 mL) Purposes Acetaminophen 160 mg Pain reliever/fever reducer Dextromethorphan HBr 5 mg Cough suppressant"],"purpose_table":["
Active ingredients (in each 5 mL)Purposes
Acetaminophen 160 mgPain reliever/fever reducer
Dextromethorphan HBr 5 mgCough suppressant
"],"questions":["Questions or comments? 1-866-467-2748"],"set_id":"27820bce-6638-4f17-ac66-62b02b76bec3","spl_product_data_elements":["CVS Childrens COLD PLUS COUGH PLUS SORE THROAT Acetaminophen and Dextromethorphan Hydrobromide ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED ANHYDROUS CITRIC ACID D&C RED NO. 33 EDETATE DISODIUM FD&C RED NO. 40 GLYCERIN MICROCRYSTALLINE CELLULOSE WATER SODIUM BENZOATE TRISODIUM CITRATE DIHYDRATE SORBITOL SOLUTION SUCRALOSE XANTHAN GUM"],"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"],"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. ▪ 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 ▪ 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 When using this product ▪ do not exceed recommended dose (see overdose warning ) 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 at 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 )"]}