{"active_ingredient":["Active ingredients (in each 5 mL) Acetaminophen 325 mg Chlorpheniramine maleate 2 mg Dextromethorphan HBr 6.5 mg Phenylephrine HCl 5 mg"],"ask_doctor":["Ask a doctor or pharmacist before use if the child has liver disease heart disease high blood pressure thyroid disease diabetes glaucoma a breathing problem such as chronic bronchitis cough that occurs with too much phlegm (mucus) chronic cough that lasts such as occurs with asthma"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin taking sedatives or tranquilizers"],"do_not_use":["Do not use in a child under 4 years of age if your child is allergic to acetaminophen or any inactive ingredient in this product 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. to make your child sleepy"],"dosage_and_administration":["Directions this product does not contain directions or complete warnings for adult use do not give more than directed use enclosed dosing cup keep dosing cup for use with this product mL = milliliter children under 6 years of age Do not use children 6 to under 12 years of age 5 mL every 4-6 hours, not to exceed 5 doses in 24 hours children 12 years and over 10 mL every 4-6 hours, not to exceed 6 doses in 24 hours"],"dosage_and_administration_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td>children under 6 years of age</td><td>Do not use</td></tr><tr><td>children 6 to under 12 years of age</td><td>5 mL every 4-6 hours, not to exceed 5 doses in 24 hours</td></tr><tr><td>children 12 years and over</td><td>10 mL every 4-6 hours, not to exceed 6 doses in 24 hours</td></tr></tbody></table>"],"effective_time":"20251009","id":"40b8865e-4141-75bb-e063-6394a90aafba","inactive_ingredient":["Inactive ingredients Citric acid, disodium EDTA, flavor, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water and sucralose"],"indications_and_usage":["Uses temporarily relieves: minor aches and pains headache minor sore throat pain runny nose itchy nose or throat sneezing itchy watery eyes due to hay fever nasal and sinus congestion cough due to minor throat and bronchial irritation as may occur with a cold temporarily reduces fever"],"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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"openfda":{"application_number":["M012"],"brand_name":["Giltuss Childrens MultiSymptom Cold and Flu"],"generic_name":["ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Giltuss Pharmaceutical Corp"],"package_ndc":["58552-137-04"],"product_ndc":["58552-137"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["2121065"],"spl_id":["40b8865e-4141-75bb-e063-6394a90aafba"],"spl_set_id":["852c8cd6-271f-0fa8-e053-2991aa0ab179"],"substance_name":["CHLORPHENIRAMINE MALEATE","PHENYLEPHRINE HYDROCHLORIDE","DEXTROMETHORPHAN HYDROBROMIDE","ACETAMINOPHEN"],"unii":["V1Q0O9OJ9Z","04JA59TNSJ","9D2RTI9KYH","362O9ITL9D"]},"other_safety_information":["Other information store at room temperature 15° - 30°C (59° - 86°F) close cap tightly SAVE CARTON FOR COMPLETE DRUG FACTS"],"package_label_principal_display_panel":["Children's Giltuss® MULTI-SYMPTOM COLD & FLU ANALGESIC, ANTITUSSIVE, ANTIHISTAMINE & NASAL DECONGESTANT Alcohol Free. Sodium Free. Sugar Free. Dye Free FEVER, HEADACHE AND BODY ACHES COUGH AND COLD STUFFY NOSE SNEEZING AND RUNNY NOSE STRAWBERRY FLAVOR 4FL OZ (118 mL) 58552-137 Child Multisymptom"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding , ask a health professional before use."],"purpose":["Purposes Pain reliever/fever reducer Antihistamine Cough Suppressant Nasal decongestant"],"questions":["Questions or comments? Call 1-787-848-9114, Monday-Friday 9AM - 5PM EST. Call your doctor for medical advice in the event of side effects."],"set_id":"852c8cd6-271f-0fa8-e053-2991aa0ab179","spl_product_data_elements":["Giltuss Childrens MultiSymptom Cold and Flu Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride POLYETHYLENE GLYCOL, UNSPECIFIED ANHYDROUS CITRIC ACID PROPYLPARABEN GLYCERIN PROPYLENE GLYCOL WATER SUCRALOSE EDETATE DISODIUM EDETIC ACID METHYLPARABEN CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ACETAMINOPHEN ACETAMINOPHEN Light yellow"],"spl_unclassified_section":["Drug Facts","Tamper evident: do not use if safety seal is broken or missing MANUFACTURED FOR GIL PHARMACEUTICAL CORP. PONCE, PUERTO RICO 00717-1565"],"stop_use":["Stop use and ask a doctor if nervousness, dizzyness or sleeplessness pain, nasal congestion, or cough gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition."],"version":"6","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 marked drowsiness may occur excitability may occur, especially in children"]}