{ "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": "2026-10-21", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "Capmist DM Dextromethorphan Hydrobromide, Guaifenesin and Pseudoephedrine Hydrochloride FD&C BLUE NO. 1 FD&C YELLOW NO. 5 MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A POTATO DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE light green CAP;DM oblong" ], "spl_unclassified_section": [ "Drug Facts", "Other information Store at 15°-30°C (59°-86°F). Capmist DM is a light green, oblong, capsule shaped, scored tablet, debossed “CAP” bisect “DM” on one side and blank on the other. Contains color additives including FD&C Yellow No. 5 (tartrazine). Supplied in a tight, light-resistant container with a child-resistant cap." ], "active_ingredient": [ "Active ingredients (in each tablet) Dextromethorphan HBr 15mg", "Active ingredients (in each tablet) Guaifenesin 400mg", "Active ingredients (in each tablet) Pseudoephedrine HCl 60mg" ], "purpose": [ "Purpose Cough Suppressant", "Purpose Expectorant", "Purpose Nasal Decongestant" ], "indications_and_usage": [ "Uses Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: cough due to minor throat and bronchial irritation helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive nasal congestion reduces swelling of nasal passages" ], "warnings": [ "Warnings Do not exceed recommended dosage. Do not use this product 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 a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema a cough that occurs with too much phlegm (mucus) heart disease high blood pressure thyroid disease diabetes trouble urinating due to enlargement of the prostate gland Stop use and ask a doctor if: nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by 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." ], "do_not_use": [ "Do not use this product 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_doctor": [ "Ask a doctor before use if you have a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema a cough that occurs with too much phlegm (mucus) heart disease high blood pressure thyroid disease diabetes trouble urinating due to enlargement of the prostate gland" ], "stop_use": [ "Stop use and ask a doctor if: nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by 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: 1 tablet every 4 hours, not to exceed 4 tablets in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: 1/2 tablet every 4 hours, not to exceed 2 tablets in 24 hours, or as directed by a doctor. Children 2 to under 6 years of age: Consult a doctor." ], "dosage_and_administration_table": [ "
Do not exceed recommended dosage.
Adults and children 12 years of age and over:1 tablet every 4 hours, not to exceed 4 tablets in 24 hours, or as directed by a doctor.
Children 6 to under 12 years of age:1/2 tablet every 4 hours, not to exceed 2 tablets in 24 hours, or as directed by a doctor.
Children 2 to under 6 years of age:Consult a doctor.
" ], "inactive_ingredient": [ "Inactive ingredients FD&C Blue #1, FD&C Yellow #5, Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 29978-601-90 CAPMIST DM Tablets Cough Suppressant ● Expectorant Nasal Decongestant 90 tablets PRINCIPAL DISPLAY PANEL NDC 29978-601-90 CAPMIST DM Tablets Cough Suppressant ● Expectorant Nasal Decongestant 90 tablets", "PRINCIPAL DISPLAY PANEL NDC 29978-601-30 CAPMIST DM Tablets Cough Suppressant ● Expectorant Nasal Decongestant 3 0 samples PRINCIPAL DISPLAY PANEL NDC 29978-601-30 CAPMIST DM Tablets Cough Suppressant ● Expectorant Nasal Decongestant 30 samples" ], "set_id": "63733ac3-859e-4a8e-8717-d852bd303408", "id": "45134129-e509-ebf0-e063-6294a90a03cd", "effective_time": "20251203", "version": "9", "openfda": { "application_number": [ "M012" ], "brand_name": [ "Capmist DM" ], "generic_name": [ "DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE" ], "manufacturer_name": [ "Capital Pharmaceutical, LLC" ], "product_ndc": [ "29978-601" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DEXTROMETHORPHAN HYDROBROMIDE", "GUAIFENESIN", "PSEUDOEPHEDRINE HYDROCHLORIDE" ], "rxcui": [ "1426660" ], "spl_id": [ "45134129-e509-ebf0-e063-6294a90a03cd" ], "spl_set_id": [ "63733ac3-859e-4a8e-8717-d852bd303408" ], "package_ndc": [ "29978-601-30", "29978-601-90" ], "is_original_packager": [ true ], "upc": [ "0329978601904" ], "nui": [ "N0000193956", "N0000008867", "N0000009560" ], "pharm_class_epc": [ "Expectorant [EPC]" ], "pharm_class_pe": [ "Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]" ], "unii": [ "9D2RTI9KYH", "495W7451VQ", "6V9V2RYJ8N" ] } } ] }