{"active_ingredient":["Active ingredients (in each 5 mL) Chlorpheniramine maleate USP, 2 mg Dextromethorphan HBr USP, 10 mg Phenylephrine HCl USP, 5 mg"],"ask_doctor":["Ask a doctor before use if the child has heart disease high blood pressure thyroid disease diabetes glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or persistent or 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 sedatives or tranquilizers taking any other oral nasal decongestant or stimulant"],"do_not_use":["Do not use to sedate a child or to make a child sleepy 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 taking this product."],"dosage_and_administration":["Directions not take more than 6 doses in any 24-hour period use enclosed dosing cup keep dosage cup for use with this product mL=milliter children under 6 years Consult a Doctor children 6 to under 12 years 5 mL every 4 to 6 hours adults and children 12 years and over 10 mL every 4 to 6 hours"],"dosage_and_administration_table":["
children under 6 yearsConsult a Doctor
children 6 to under 12 years5 mL every 4 to 6 hours
adults and children 12 years and over10 mL every 4 to 6 hours
"],"effective_time":"20251009","id":"40b8adbf-d8c9-a01a-e063-6394a90a45ff","inactive_ingredient":["Inactive ingredients citric acid, flavor, glycerin, methylparaben, propylparaben, purified water and sucralose"],"indications_and_usage":["Uses temporarily relieves cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves these symptoms due to hay fever (allergic rhinitis): runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily restores freer breathing through the nose"],"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":["Giltuss Childrens Allergy Plus Cough and Congestion"],"generic_name":["CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Gil Pharmaceutical Corp"],"package_ndc":["58552-139-04"],"product_ndc":["58552-139"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1363752"],"spl_id":["40b8adbf-d8c9-a01a-e063-6394a90a45ff"],"spl_set_id":["852c5a57-7ee4-3c5c-e053-2a91aa0a1433"],"substance_name":["CHLORPHENIRAMINE MALEATE","DEXTROMETHORPHAN HYDROBROMIDE","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["V1Q0O9OJ9Z","9D2RTI9KYH","04JA59TNSJ"]},"package_label_principal_display_panel":["Children's Giltuss® ALLERGY PLUS COUGH & CONGESTION ANTIHISTAMINIC, ANTITUSSIVE, & NASAL DECONGESTANT Alcohol Free. Sodium Free. Sugar Free. Dye Free. SNEEZING RUNNY NOSE COUGH ITCHY & WATERY EYES STUFFY NOSE SINUS PRESSURE TUTTI FRUTTI FLAVOR 4 FL OZ (118 mL) 58552-139 Child Allergy Cough Congestion"],"pregnancy_or_breast_feeding":["If pregnant or breastfeeding, ask a health professional before use."],"purpose":["Purposes 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":"852c5a57-7ee4-3c5c-e053-2a91aa0a1433","spl_product_data_elements":["Giltuss Childrens Allergy Plus Cough and Congestion CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE PROPYLPARABEN METHYLPARABEN GLYCERIN WATER ANHYDROUS CITRIC ACID SUCRALOSE CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE 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 giltuss.com"],"stop_use":["Stop use and ask a doctor if nervousness, dizzyness, or sleepless occurs symptoms do not get better within 7 days or are accompanied by a fever cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition."],"storage_and_handling":["Other information store at room temperature 15° - 30°C (59° - 86°F) close cap tightly SAVE CARTON FOR COMPLETE DRUG FACTS"],"version":"6","warnings":["Warnings Do not use to sedate a child or to make a child sleepy 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 taking this product. Ask a doctor before use if the child has heart disease high blood pressure thyroid disease diabetes glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or persistent or chronic cough that lasts such as occurs with asthma Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers taking any other oral nasal decongestant or stimulant When using this product do not use more than directed may cause marked drowsiness excitability may occur, especially in children Stop use and ask a doctor if nervousness, dizzyness, or sleepless occurs symptoms do not get better within 7 days or are accompanied by a fever cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition. If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"when_using":["When using this product do not use more than directed may cause marked drowsiness excitability may occur, especially in children"]}