{ "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": "2026-10-14", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "MAR-COF CG Expectorant CODEINE PHOSPHATE and GUAIFENESIN CITRIC ACID MONOHYDRATE GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SACCHARIN SODIUM SORBITOL CODEINE PHOSPHATE CODEINE ANHYDROUS GUAIFENESIN GUAIFENESIN" ], "spl_unclassified_section": [ "Drug Facts" ], "active_ingredient": [ "Active ingredients (in each teaspoonful (5 mL)) Purpose Codeine Phosphate 7.5 mg Antitussive Guaifenesin 225 mg Expectorant" ], "active_ingredient_table": [ "
Active ingredients (in each teaspoonful (5 mL))Purpose
Codeine Phosphate 7.5 mgAntitussive
Guaifenesin 225 mgExpectorant
" ], "purpose": [ "Active ingredients (in each teaspoonful (5 mL)) Purpose Codeine Phosphate 7.5 mg Antitussive Guaifenesin 225 mg Expectorant" ], "purpose_table": [ "
Active ingredients (in each teaspoonful (5 mL))Purpose
Codeine Phosphate 7.5 mgAntitussive
Guaifenesin 225 mgExpectorant
" ], "indications_and_usage": [ "Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants your cough to help you sleep helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes cough more productive." ], "warnings": [ "Warnings Ask your doctor before use if you have a persistent cough, this may be a sign of a serious condition you have a persistent cough such as occurs with smoking, asthma, chronic bronchitis or emphysema you have a cough that is accompanied by excessive phlegm (mucus) you have chronic pulmonary disease or shortness of breath giving to a child who is taking other drugs When using this product giving a higher dose than recommended by a doctor could result in serious side effects for your child. A special measuring device should be used to give an accurate dose of this product to children under 6 years of age may cause or aggravate constipation Stop use and ask a doctor if symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash or persistent headache. These may be symptoms of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "ask_doctor": [ "Ask your doctor before use if you have a persistent cough, this may be a sign of a serious condition you have a persistent cough such as occurs with smoking, asthma, chronic bronchitis or emphysema you have a cough that is accompanied by excessive phlegm (mucus) you have chronic pulmonary disease or shortness of breath giving to a child who is taking other drugs" ], "when_using": [ "When using this product giving a higher dose than recommended by a doctor could result in serious side effects for your child. A special measuring device should be used to give an accurate dose of this product to children under 6 years of age may cause or aggravate constipation" ], "stop_use": [ "Stop use and ask a doctor if symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash or persistent headache. These may be symptoms of a serious condition." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "keep_out_of_reach_of_children": [ "Keep out of the 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 6 doses in 24 hours. Adults and children 12 years of age and over 1 ½ tsp (7.5 mL) every 4-6 hours Children 6 to under 12 years of age ¾ tsp (3.75 mL) every 4-6 hours Children under 6 years of age Consult a doctor" ], "dosage_and_administration_table": [ "
Adults and children 12 years of age and over1 ½ tsp (7.5 mL) every 4-6 hours
Children 6 to under 12 years of age¾ tsp (3.75 mL) every 4-6 hours
Children under 6 years of ageConsult a doctor
" ], "storage_and_handling": [ "Other information Each teaspoonful contains 6 mg of sodium. Store at controlled room temperature 15°-30°C (59°-86°F)." ], "inactive_ingredient": [ "Inactive ingredients Citric Acid, Flavors, Glycerin, Polyethylene Glycol, Povidone, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, and Sorbitol" ], "how_supplied": [ "Distributed and Marketed By: Allegis Pharmaceuticals, LLC 276 Nissan Parkway, F100 Canton, MS 39046" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label MARNEL NDC 0682-0475-16 MAR-COF ® CG EXPECTORANT ANTITUSSIVE (cough suppressant) EXPECTORANT Each 5mL (one teaspoonful) for oral administration contains: Codeine Phosphate 7.5 mg Guaifenesin 225 mg Alcohol-Free / Sugar-Free TAMPER EVIDENT: Do not use if imprinted safety seal under cap is broken or missing. 16 fl. oz. (473 mL) Label" ], "set_id": "60a41229-b125-43d8-b2b4-0bf40feed764", "id": "13b802bb-b30a-864a-e063-6394a90a4dfd", "effective_time": "20240315", "version": "5", "openfda": { "application_number": [ "M012" ], "brand_name": [ "MAR-COF CG Expectorant" ], "generic_name": [ "CODEINE PHOSPHATE AND GUAIFENESIN" ], "manufacturer_name": [ "Marnel Pharmaceuticals, LLC" ], "product_ndc": [ "0682-0475" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "CODEINE PHOSPHATE", "GUAIFENESIN" ], "rxcui": [ "995441", "995443" ], "spl_id": [ "13b802bb-b30a-864a-e063-6394a90a4dfd" ], "spl_set_id": [ "60a41229-b125-43d8-b2b4-0bf40feed764" ], "package_ndc": [ "0682-0475-16" ], "is_original_packager": [ true ], "upc": [ "0306820475166" ], "nui": [ "N0000193956", "N0000008867", "N0000009560" ], "pharm_class_epc": [ "Expectorant [EPC]" ], "pharm_class_pe": [ "Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]" ], "unii": [ "GSL05Y1MN6", "495W7451VQ" ] } } ] }