{"active_ingredient":["Active ingredients (in each 5 mL) Acetaminophen 160 mg Chlorpheniramine maleate 1 mg Dextromethorphan HBr 5 mg Phenylephrine HCl 2.5 mg Purposes Pain reliever/fever reducer Antihistamine Cough suppressant Nasal decongestant"],"dosage_and_administration":["Directions this product does not contain directions or complete warnings for adult use mL = milliliter shake well before using do not give more than 5 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. keep dosing cup with product if needed, repeat dose every 4 hours while symptoms last find the right dose on chart below. If possible, use weight to dose; otherwise, use age. Weight (lb) Age (yr) Dose (mL) 48-95 6-11 10 mL 36-47 4-5 do not use unless directed by a doctor under 36 under 4 do not use"],"dosage_and_administration_table":["<table width=\"100%\"><caption/><tbody><tr><td>Weight (lb)</td><td>Age (yr)</td><td>Dose (mL)</td></tr><tr><td>48-95</td><td>6-11</td><td>10 mL</td></tr><tr><td>36-47</td><td>4-5</td><td>do not use unless directed by a doctor</td></tr><tr><td>under 36</td><td>under 4</td><td>do not use</td></tr><tr><td/><td/><td/></tr></tbody></table>"],"effective_time":"20240123","id":"0fa5123b-60d0-3f93-e063-6394a90aa1ae","inactive_ingredient":["Inactive ingredients carboxymethylcellulose sodium, citric acid, D&C red #33, FD&C blue #1, FD&C red #40, flavor, glycerin, microcrystalline cellulose, purified water, sodium benzoate, sorbitol, sucrose, xanthan gum"],"indications_and_usage":["Uses • temporarily relieves the following cold/flu symptoms • minor aches and pains • sore throat • cough • sneezing and runny nose • headache • nasal congestion • stuffy nose • temporarily reduces fever"],"keep_out_of_reach_of_children":["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 for adults as well as children even if you do not notice any signs or symptoms."],"openfda":{},"package_label_principal_display_panel":["01b LBL_Calmadol Plus_4oz"],"purpose":["Purposes Pain reliever/fever reducer Antihistamine Cough suppressant Nasal decongestant"],"set_id":"998cf528-5993-4493-b080-5e2c4ac0a411","spl_product_data_elements":["Calmadol Plus ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE CARBOXYMETHYLCELLULOSE SODIUM CITRIC ACID MONOHYDRATE D&C RED NO. 33 FD&C BLUE NO. 1 FD&C RED NO. 40 METHYL SALICYLATE GLYCERIN CELLULOSE, MICROCRYSTALLINE WATER SODIUM BENZOATE SORBITOL SUCROSE XANTHAN GUM ACETAMINOPHEN ACETAMINOPHEN CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE"],"storage_and_handling":["Other information • store between 20-25°C (68-77°F). Do not refrigerate."],"version":"7","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes: • more than 5 doses (10 mL) 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. 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 for adults as well as children even if you do not notice any signs or symptoms."]}