{ "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": "2026-06-03", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "spl_product_data_elements": [ "VANACOF CP Allergy / Cough Chlophedianol HCl, Pyrilamine Maleate SODIUM CITRATE SODIUM BENZOATE PROPYLENE GLYCOL WATER SORBITOL GLYCERIN ANHYDROUS CITRIC ACID SACCHARIN SODIUM CHLOPHEDIANOL HYDROCHLORIDE CHLOPHEDIANOL PYRILAMINE MALEATE PYRILAMINE" ], "active_ingredient": [ "Active Ingredients (in each 15 mL (1TBSP)) Chlophedianol HCl 12.5 mg Pyrilamine Maleate 25 mg" ], "purpose": [ "Purpose Cough Suppressant Antihistamine" ], "indications_and_usage": [ "Uses ■ temporarily relieves these symptoms due to the common cold, hay fever or other upper respiratory allergies: ■ runny nose ■ itching of the nose or throat ■ sneezing ■ 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 ■ glaucoma ■ difficulty in urination due to enlargement of the prostate gland ■ a cough that occurs with too much phlegm (mucus) ■ a breathing problem such as emphysema or chronic bronchitis Ask a doctor before use if you are taking sedatives or tranquilizers When using this product ■ do not use more than directed ■ avoid alcoholic drinks ■ marked drowsiness may occur ■ alcohol, sedatives, and tranquilizers may increase drowsiness ■ be careful when driving a motor vehicle or operating machinery ■ excitability may occur, especially in children Stop use and ask a doctor if ■ nervousness, dizziness, or sleeplessness occurs ■ symptoms do not improve within 7 days, tend to recur, or are 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 ■ glaucoma ■ difficulty in urination due to enlargement of the prostate gland ■ a cough that occurs with too much phlegm (mucus) ■ a breathing problem such as emphysema or chronic bronchitis", "Ask a doctor before use if you are taking sedatives or tranquilizers" ], "when_using": [ "When using this product ■ do not use more than directed ■ avoid alcoholic drinks ■ marked drowsiness may occur ■ alcohol, sedatives, and tranquilizers may increase drowsiness ■ be careful when driving a motor vehicle or operating machinery ■ excitability may occur, especially in children" ], "stop_use": [ "Stop use and ask a doctor if ■ nervousness, dizziness, or sleeplessness occurs ■ symptoms do not improve within 7 days, tend to recur, or are 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 take more than 4 doses in any 24-hour period ■ dose as follows or as directed by a doctor ■ mL= milliliter adults and children 12 years of age and over: 30 mL (2 TBSP) every 6 to 8 hours, not to exceed 120 mL (8 TBSP) per 24 hours children 6 to under 12 years of age: 15 mL (1 TBSP) every 6 to 8 hours, not to exceed 60 mL (4 TBSP) per 24 hours children under 6 years: consult a doctor." ], "dosage_and_administration_table": [ "
adults and children 12 years of age and over:30 mL (2 TBSP) every 6 to 8 hours, not to exceed 120 mL (8 TBSP) per 24 hours
children 6 to under 12 years of age:15 mL (1 TBSP) every 6 to 8 hours, not to exceed 60 mL (4 TBSP) per 24 hours
children under 6 years:consult a doctor.
" ], "storage_and_handling": [ "Other information ■ store at 20° to 30°C (68° to 86°F) ■ each 15 mL (1 TBSP) contains: Sodium 8.5 mg" ], "inactive_ingredient": [ "Inactive ingredients citric acid anhydrous, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol" ], "questions": [ "Questions? 1-888-535-0305 9 a.m. - 5 p.m. CST" ], "other_safety_information": [ "Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing." ], "spl_unclassified_section": [ "U.S. Pat: 9,463,191 Distributed by: GM Pharmaceuticals, Inc. Arlington, TX 76018" ], "package_label_principal_display_panel": [ "NDC 58809-189-08 VANACOF ® CP Allergy / Cough Each 15 mL (1 TBSP) contains: Chlophedianol HCl .................... 12.5 mg Pyrilamine Maleate ....................... 25 mg Cough Suppressant • Antihistamine Alcohol Free / Sugar Free / Gluten Free / Dye Free GM Pharmaceuticals, Inc. 8 fl oz (237 mL) VanaCof CP" ], "set_id": "0bdea30a-39da-6611-e063-6394a90aa4cf", "id": "41209869-f054-7352-e063-6294a90aa5ab", "effective_time": "20251014", "version": "6", "openfda": { "application_number": [ "M012" ], "brand_name": [ "VANACOF CP Allergy / Cough" ], "generic_name": [ "CHLOPHEDIANOL HCL, PYRILAMINE MALEATE" ], "manufacturer_name": [ "GM Pharmaceuticals, INC" ], "product_ndc": [ "58809-189" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "CHLOPHEDIANOL HYDROCHLORIDE", "PYRILAMINE MALEATE" ], "rxcui": [ "2672917" ], "spl_id": [ "41209869-f054-7352-e063-6294a90aa5ab" ], "spl_set_id": [ "0bdea30a-39da-6611-e063-6394a90aa4cf" ], "package_ndc": [ "58809-189-08" ], "is_original_packager": [ true ], "upc": [ "0358809189083" ], "unii": [ "69QQ58998Y", "R35D29L3ZA" ] } } ] }