{ "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": "2026-08-11", "results": { "skip": 0, "limit": 1, "total": 7 } }, "results": [ { "spl_product_data_elements": [ "Codeine-Guaifenesin Codeine Phosphate and Guaifenesin Codeine Phosphate Codeine Anhydrous Guaifenesin Guaifenesin CITRIC ACID MONOHYDRATE GLYCERIN PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCRALOSE" ], "spl_unclassified_section": [ "Drug Facts" ], "active_ingredient": [ "Active ingredients (in each 5 mL = 1 tsp) Purpose Codeine phosphate, USP 10 mg Antitussive Guaifenesin, USP 100 mg Expectorant" ], "active_ingredient_table": [ "
Active ingredients (in each 5 mL = 1 tsp)Purpose
Codeine phosphate, USP 10 mg Antitussive
Guaifenesin, USP 100 mgExpectorant
" ], "purpose": [ "Active ingredients (in each 5 mL = 1 tsp) Purpose Codeine phosphate, USP 10 mg Antitussive Guaifenesin, USP 100 mg Expectorant" ], "purpose_table": [ "
Active ingredients (in each 5 mL = 1 tsp)Purpose
Codeine phosphate, USP 10 mg Antitussive
Guaifenesin, USP 100 mgExpectorant
" ], "indications_and_usage": [ "Uses • temporarily relieves: o cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants o your cough to help you sleep o helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs 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: 2 tsp (10 mL) every 4 hours, or as directed by a doctor. Children 6 to under 12 years of age: 1 tsp (5 mL) every 4 hours, or as directed by a doctor. Children under 6 years of age: Consult a doctor." ], "dosage_and_administration_table": [ "
Adults and children 12 years of age and over:2 tsp (10 mL) every 4 hours, or as directed by a doctor.
Children 6 to under 12 years of age:1 tsp (5 mL) every 4 hours, or as directed by a doctor.
Children under 6 years of age:Consult a doctor.
" ], "storage_and_handling": [ "Other information Store at controlled room temperature 15°-30°C (59°-86°F). You may report side effects by calling 1-844-221-7294 or FDA at 1-800-FDA-1088." ], "inactive_ingredient": [ "Inactive ingredients Cherry Flavor, Citric Acid Anhydrous, Glycerin, Masking Agent, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sorbitol Solution, Sucralose." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label NDC 71205-624-04 Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive/Expectorant Sugar Free, Alcohol Free, Dye Free Each 5 mL (1 teaspoonful) contains: Codeine phosphate, USP 10 mg Guaifenesin, USP 100 mg (WARNING: May be habit-forming) 4 fl. oz. (118 mL) 71205-624-04" ], "set_id": "20f35f9f-5f3b-4305-b9e4-ab9a8fae9c1d", "id": "f2b561b1-fe8c-440e-a290-ef7522f7da7e", "effective_time": "20241001", "version": "2", "openfda": { "application_number": [ "M012" ], "brand_name": [ "Codeine-Guaifenesin" ], "generic_name": [ "CODEINE PHOSPHATE AND GUAIFENESIN" ], "manufacturer_name": [ "Proficient Rx LP" ], "product_ndc": [ "71205-624" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "CODEINE PHOSPHATE", "GUAIFENESIN" ], "rxcui": [ "995868" ], "spl_id": [ "f2b561b1-fe8c-440e-a290-ef7522f7da7e" ], "spl_set_id": [ "20f35f9f-5f3b-4305-b9e4-ab9a8fae9c1d" ], "package_ndc": [ "71205-624-04" ], "original_packager_product_ndc": [ "69367-272" ], "nui": [ "N0000193956", "N0000008867", "N0000009560" ], "pharm_class_epc": [ "Expectorant [EPC]" ], "pharm_class_pe": [ "Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]" ], "unii": [ "GSL05Y1MN6", "495W7451VQ" ] } } ] }