{"active_ingredient":["Active ingredients (in each 10 mL) Acetaminophen 650 mg Chlorpheniramine maleate 4 mg Dextromethorphan hydrobromide 13 mg Phenylephrine hydrochloride 10 mg"],"ask_doctor":["Ask a doctor or pharmacist before use if the user 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 smoking, asthma, or emphysema trouble urinating due to enlargement of the prostate gland"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin taking sedatives or tranquilizers"],"do_not_use":["Do not use if you are 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. if you are now 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."],"dosage_and_administration":["Directions do not give more than directed use enclosed dosing cup keep dosing cup for use with this product mL = milliliter adults and children 12 years and over 10 mL every 4-6 hours, not to exceed 6 doses in 2 hours children 6 to under 12 years of age 5 mL every 4-6 hours, not to exceed 5 doses in 24 hours children under 6 years of age Do not use"],"dosage_and_administration_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td>adults and children 12 years and over</td><td>10 mL every 4-6 hours, not to exceed 6 doses in 2 hours</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 under 6 years of age</td><td>Do not use</td></tr></tbody></table>"],"effective_time":"20251009","id":"40b884bc-bd0f-ef2f-e063-6294a90abd76","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. Quick 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 MultiSymptom Cold and Flu"],"generic_name":["ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Giltuss Pharmaceutical Corp"],"package_ndc":["58552-136-04"],"product_ndc":["58552-136"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["2121065"],"spl_id":["40b884bc-bd0f-ef2f-e063-6294a90abd76"],"spl_set_id":["8518fd91-981e-de78-e053-2a91aa0afcb2"],"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":["MAXIMUM STRENGTH Giltuss® MULTI-SYMPTOM COLD & FLU ANALGESIC, ANTITUSSIVE, ANTIHISTAMINE & NASAL DECONGESTANT ALCOHOL FREE. SODIUM FREE. SUGAR FREE. DYE FREE RELIEVES FEVER, HEADACHE AND BODY ACHES COUGH AND COLD SNEEZING RUNNY NOSE ITCHY AND WATERY EYES STUFFY NOSE SINUS PRESSURE STRAWBERRY FLAVOR 4FL OZ (118 mL) 58552-136"],"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":"8518fd91-981e-de78-e053-2a91aa0afcb2","spl_product_data_elements":["Giltuss 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 you get nervousness, dizzyness or sleeplessness pain, nasal congestion, or cough gets worse or lasts more than 7 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: adult takes more than 6 doses in 24 hours, which is the maximum daily amount child takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash hives facial swelling asthma (wheezing) shock 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 avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery"]}