{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-06-01", "results": { "skip": 0, "limit": 1, "total": 7 } }, "results": [ { "spl_product_data_elements": [ "VanaCof 2 Chlophedianol HCl, Dexchlorpheniramine Maleate WATER PROPYLENE GLYCOL SODIUM BENZOATE SORBITOL SOLUTION DEXCHLORPHENIRAMINE MALEATE DEXCHLORPHENIRAMINE CHLOPHEDIANOL HYDROCHLORIDE CHLOPHEDIANOL ANHYDROUS CITRIC ACID SUCRALOSE GLYCERIN TRISODIUM CITRATE DIHYDRATE" ], "active_ingredient": [ "Active ingredients in each 5 mL (1 teaspoonful) Chlophedianol HCI 12.5 mg Dexchlorpheniramine Maleate 1 mg" ], "purpose": [ "Purpose Cough Suppressant Antihistamine" ], "indications_and_usage": [ "Uses ■ temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: ■ runny nose ■ sneezing ■ itching of the nose or throat ■ itchy, watery eyes ■ cough due to minor throat and bronchial irritation" ], "warnings": [ "Warnings Ask a doctor before use if you have ■ a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema ■ a cough that occurs with too much phlegm (mucus) ■ a breathing problem such as emphysema or chronic bronchitis ■ trouble urinating due to an enlarged prostate gland ■ glaucoma Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product ■ excitability may occur, especially in children ■ may cause marked drowsiness ■ alcohol, sedatives, and tranquilizers may increase the drowsiness effect ■ avoid alcoholic drinks ■ use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if ■ cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition. ■ new symptoms occur If pregnant or breast-feeding, 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." ], "ask_doctor": [ "Ask a doctor before use if you have ■ a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema ■ a cough that occurs with too much phlegm (mucus) ■ a breathing problem such as emphysema or chronic bronchitis ■ trouble urinating due to an enlarged prostate gland ■ glaucoma" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers" ], "when_using": [ "When using this product ■ excitability may occur, especially in children ■ may cause marked drowsiness ■ alcohol, sedatives, and tranquilizers may increase the drowsiness effect ■ avoid alcoholic drinks ■ use caution when driving a motor vehicle or operating machinery" ], "stop_use": [ "Stop use and ask a doctor if ■ cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition. ■ new symptoms occur" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "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." ], "dosage_and_administration": [ "Directions do not exceed recommended dosage. adults and children 12 years of age and over: 2 teaspoonfuls (10 mL) every 6 hours, not to exceed 8 teaspoonfuls (40 mL) in 24 hours. children 6 to under 12 years of age: 1 teaspoonful (5 mL) every 6 hours, not to exceed 4 teaspoonfuls (20 mL) in 24 hours. children under 6 years of age: consult a doctor." ], "dosage_and_administration_table": [ "
adults and children 12 years of age and over:2 teaspoonfuls (10 mL) every 6 hours, not to exceed 8 teaspoonfuls (40 mL) in 24 hours.
children 6 to under 12 years of age:1 teaspoonful (5 mL) every 6 hours, not to exceed 4 teaspoonfuls (20 mL) in 24 hours.
children under 6 years of age:consult a doctor.
" ], "storage_and_handling": [ "Other information ■ this packaging is child-resistant. ■ store at room temperature of 68°-86°F (20°-30°C) with excursions of 59°-86°F (15°-30°C)" ], "inactive_ingredient": [ "Inactive ingredients citric acid anhydrous, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose" ], "questions": [ "Questions? Call 1-888-535-0305 9a.m. - 5p.m. CST" ], "spl_unclassified_section": [ "Distributed by: GM Pharmaceuticals, Inc. Fort Worth, TX 76118" ], "package_label_principal_display_panel": [ "NDC 58809-190-16 VanaCof® 2 EACH 5 mL (1 TEASPOONFUL) CONTAINS: Chlophedianol HCI..........................12.5 mg Dexchlorpheniramine Maleate............1 mg Cough Suppressant Antihistamine Sugar Free, Alcohol Free, Dye Free Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing. THIS BOTTLE IS NOT TO BE DISPENSED TO CONSUMER. Dispense in a tight, light-resistant container with a child-resistant cap. US Patent # 9,463,191 US Patent # 9,050,289 GM Pharmaceuticals, Inc. 16 fl. oz. (473 mL) VanaCof 2 Label" ], "set_id": "0c7c6756-abb2-c10c-e063-6394a90a9863", "id": "47e37a4b-be9d-3c99-e063-6394a90ac7c7", "effective_time": "20260108", "version": "5", "openfda": { "application_number": [ "M012" ], "brand_name": [ "VanaCof 2" ], "generic_name": [ "CHLOPHEDIANOL HCL, DEXCHLORPHENIRAMINE MALEATE" ], "manufacturer_name": [ "GM Pharmaceuticals, INC" ], "product_ndc": [ "58809-190" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "CHLOPHEDIANOL HYDROCHLORIDE", "DEXCHLORPHENIRAMINE MALEATE" ], "rxcui": [ "2671454" ], "spl_id": [ "47e37a4b-be9d-3c99-e063-6394a90ac7c7" ], "spl_set_id": [ "0c7c6756-abb2-c10c-e063-6394a90a9863" ], "package_ndc": [ "58809-190-16" ], "is_original_packager": [ true ], "upc": [ "0358809190164" ], "unii": [ "69QQ58998Y", "B10YD955QW" ] } } ] }