{"active_ingredient":["Drug Facts Active ingredients Purpose (in each 10 mL) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg"],"dosage_and_administration":["Directions • do not use more than directed (see Overdose warning) • shake well before using • do not use more than 5 doses in any 24-hour period • if needed, repeat dose every 4 hours while symptoms last • do not use more than 5 days unless directed by a doctor • use dosage cup Age Dose Children 6 to under 12 years of age 10 mL every 4 hours Children under 6 years of age Do not use"],"dosage_and_administration_table":["<table width=\"400px\"><caption>Age Dose</caption><tbody><tr><td> Children 6 to under 12 years of age</td><td> 10 mL every 4 hours</td></tr><tr><td>Children under 6 years of age</td><td> Do not use</td></tr></tbody></table>"],"effective_time":"20240201","id":"2f25ce5a-4e46-4e77-be6d-041a502a5049","inactive_ingredient":["Inactive ingredients anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, Xanthan gum"],"indications_and_usage":["Uses • temporarily relieves these common cold and flu symptoms: • nasal congestion • stuffy nose • minor aches and pains • sore throat • headache • fever • cough due to minor throat and bronchial irritation • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tube"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M012"],"brand_name":["CHILDRENS COLD COUGH and SORE THROAT MIXED BERRY"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL"],"is_original_packager":[true],"manufacturer_name":["AptaPharma Inc."],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["76281-519-24"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["76281-519"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1593450"],"spl_id":["2f25ce5a-4e46-4e77-be6d-041a502a5049"],"spl_set_id":["5962a73e-72e4-493b-94a7-43bc6cf9c82f"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["362O9ITL9D","9D2RTI9KYH","495W7451VQ","04JA59TNSJ"]},"other_safety_information":["Other information • each 10 mL contains: sodium 5 mg • store between IS-30°C (59-86°F) • do not refrigerate • dosage cup provided"],"overdosage":["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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"package_label_principal_display_panel":["Maximum Strength MAX COLD & SINUS AP SAFE NDC 76281-519-24 Compare to Mucinex ® FAST-MAX™ Cold & Sinus Active ingredients* Children's Cold, Cough & Sore Throat Pain reliever/Fever Reducer Cough Suppresant Expectorant Nasal decongestant For Ages 6 to 12 Mixed Berry Flavor 4 FL OZ ( 118 mL) DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING Manufactured by: AptaPharma Inc., 1533 Union Ave. Pennsauken, NJ 08110 * This product is not manufactured or distributed by Reckitt Benckiser Inc., distributor ofchildren's Mucinex ® Cold, Cough & Sore Throat liquid. res 519 4 Oz 519 4 Oz Botl"],"purpose":["Purpose Acetaminophen ……....…….... Pain reliever/fever reducer Dextromethorphan HBr …....Cough suppressant Guaifenesin ………….....…..…. Expectorant Phenylephrine HCI …...……….Nasal decongestant"],"questions":["Questions? Call weekdays from 9:30AM to 4:30 PM EST 1-877-798-5944"],"set_id":"5962a73e-72e4-493b-94a7-43bc6cf9c82f","spl_product_data_elements":["CHILDRENS COLD COUGH and SORE THROAT MIXED BERRY ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAIFENESIN, PHENYLEPHRINE HCL ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN PROPYLENE GLYCOL PROPYL GALLATE WATER SODIUM BENZOATE SORBITOL SUCRALOSE XANTHAN GUM"],"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 • skinreddening • blisters • rash. If 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. Ask a doctor before use if your child has • Iiver disease • heart disease • high blood pressure • thyroid disease • diabetes • a breathing problem such as chronic bronchitis • 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 use more than directed (see Overdose warning) Stop use and ask a doctor if • redness or swelling is present • nervousness, dizziness or sleeplessness occur • new symptoms occur • pain, nasal congestion or cough gets worse or lasts more than 5 days • fever gets worse or lasts more than 3 days • cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition."]}