{"active_ingredient":["Active ingredients (in each 10 mL) Chlorpheniramine maleate, USP 4 mg Dextromethorphan HBr, USP 20 mg Phenylephrine HCl, USP 10 mg"],"ask_doctor":["Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to enlargement of the prostate gland glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are 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 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 take more than 6 doses in any 24-hour period use enclosed dosing cup keep dosage cup for use with this product mL=milliter adults and children 12 years and over 10 mL every 4 to 6 hours children 6 to under 12 years 5 mL every 4 to 6 hours children under 6 years Consult a Doctor"],"dosage_and_administration_table":["<table width=\"55%\" styleCode=\"Noautorules\"><col align=\"left\" valign=\"top\" width=\"40%\"/><col align=\"left\" valign=\"top\" width=\"60%\"/><tbody><tr><td styleCode=\"Toprule Rrule\">adults and children 12 years and over</td><td styleCode=\"Toprule\">10 mL every 4 to 6 hours</td></tr><tr><td styleCode=\"Toprule Rrule\">children 6 to under 12 years</td><td styleCode=\"Toprule\">5 mL every 4 to 6 hours</td></tr><tr><td styleCode=\"Toprule Rrule\">children under 6 years</td><td styleCode=\"Toprule\">Consult a Doctor</td></tr></tbody></table>"],"effective_time":"20251009","id":"40b8aa4b-9a36-7312-e063-6394a90a7952","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, seek professional help or contact a Poison Control Center right away."],"openfda":{"application_number":["M012"],"brand_name":["Giltuss Allergy Plus Cough and Congestion"],"generic_name":["CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Gil Pharmaceutical Corp"],"package_ndc":["58552-138-04"],"product_ndc":["58552-138"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1363752"],"spl_id":["40b8aa4b-9a36-7312-e063-6394a90a7952"],"spl_set_id":["85065cf3-386d-22d5-e053-2a91aa0a72da"],"substance_name":["CHLORPHENIRAMINE MALEATE","DEXTROMETHORPHAN HYDROBROMIDE","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["V1Q0O9OJ9Z","9D2RTI9KYH","04JA59TNSJ"]},"package_label_principal_display_panel":["MAXIMUM STRENGTH Giltuss® ALLERGY PLUS COUGH & CONGESTION ANTIHISTAMINIC, ANTITUSSIVE, & NASAL DECONGESTANT ALCOHOL FREE. SODIUM FREE. SUGAR FREE. DYE FREE. RELIEVES SNEEZING RUNNY NOSE ITCHY AND WATERY EYES COUGH STUFFY NOSE SINUS PRESSURE TUTTI FRUTTI FLAVOR 4FL OZ (118 mL) 58552-138"],"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":"85065cf3-386d-22d5-e053-2a91aa0a72da","spl_product_data_elements":["Giltuss 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 you get nervous, dizzy, or sleepless 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 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. Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to enlargement of the prostate gland glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema Ask a doctor or pharmacist before use if you are 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 avoid alcoholic beverages alcohol, sedatives and tranquilizers may increase drowsiness effect be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children Stop use and ask a doctor if you get nervous, dizzy, or sleepless 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, seek professional 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 avoid alcoholic beverages alcohol, sedatives and tranquilizers may increase drowsiness effect be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children"]}