{ "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": 4 } }, "results": [ { "spl_product_data_elements": [ "Guaifenesin and Codeine Phosphate Guaifenesin and Codeine Phosphate GUAIFENESIN GUAIFENESIN CODEINE PHOSPHATE CODEINE ANHYDROUS SODIUM CITRATE, UNSPECIFIED FORM EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 FD&C YELLOW NO. 6 GLYCERIN MENTHOL, UNSPECIFIED FORM PROPYLENE GLYCOL WATER SODIUM BENZOATE ANHYDROUS CITRIC ACID SACCHARIN SODIUM SORBITOL" ], "spl_unclassified_section": [ "Drug Facts" ], "active_ingredient": [ "Active ingredients in each 5 mL (teaspoonful) Purposes Codeine Phosphate, USP 10 mg Cough Suppressant Guaifenesin, USP 100 mg Expectorant" ], "active_ingredient_table": [ "
Active ingredients in each 5 mL (teaspoonful)Purposes
Codeine Phosphate, USP 10 mgCough Suppressant
Guaifenesin, USP 100 mgExpectorant
" ], "purpose": [ "Active ingredients in each 5 mL (teaspoonful) Purposes Codeine Phosphate, USP 10 mg Cough Suppressant Guaifenesin, USP 100 mg Expectorant" ], "purpose_table": [ "
Active ingredients in each 5 mL (teaspoonful)Purposes
Codeine Phosphate, USP 10 mgCough Suppressant
Guaifenesin, USP 100 mgExpectorant
" ], "indications_and_usage": [ "Uses temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive" ], "warnings": [ "Warnings Do not use in adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, unless directed by a doctor. Ask a doctor before use if you have a cough with too much phlegm (mucus) a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if you are taking sedatives, tranquilizers and drugs used for depression, especially monoamine oxidase inhibitors (MAOIs). These combinations may cause greater sedation (drowsiness) than is caused by the product used alone. Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These can be signs of a serious condition. may cause or aggravate constipation If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Use of codeine-containing preparation is not recommended for children under 2 years of age." ], "do_not_use": [ "Do not use in adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, unless directed by a doctor." ], "ask_doctor": [ "Ask a doctor before use if you have a cough with too much phlegm (mucus) a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives, tranquilizers and drugs used for depression, especially monoamine oxidase inhibitors (MAOIs). These combinations may cause greater sedation (drowsiness) than is caused by the product used alone." ], "stop_use": [ "Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These can be signs of a serious condition. may cause or aggravate constipation" ], "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 accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Use of codeine-containing preparation is not recommended for children under 2 years of age." ], "dosage_and_administration": [ "Directions take every 4 hours do not exceed 6 doses in 24 hours a special measuring device should be used to give an accurate dose of this product to children under 6 years of age giving a higher dose than recommended by a doctor can result in serious side effects for a child adults and children 12 years and over 10 mL (2 teaspoonfuls) children 6 to under 12 years of age 5 mL (1 teaspoonful) children under 6 years of age Consult a doctor" ], "dosage_and_administration_table": [ "
adults and children 12 years and over10 mL (2 teaspoonfuls)
children 6 to under 12 years of age5 mL (1 teaspoonful)
children under 6 years of ageConsult a doctor
" ], "storage_and_handling": [ "Other information Sodium Content: 5 mg/5 mL Tamper evident: Do not use if seal under cap is broken or missing Keep container closed and store away from heat Store at 20°- 25°C (68°-77°F)" ], "inactive_ingredient": [ "Inactive ingredients Citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin and sorbitol." ], "questions": [ "Questions or comments? Call 1-800-845-8210 or visit paipharma.com Serious side effects associated with use of this product may be reported to this number." ], "how_supplied": [ "HOW SUPPLIED Product: 50090-1428 NDC: 50090-1428-0 118 mL in a BOTTLE" ], "package_label_principal_display_panel": [ "Guaifenesin and Codeine Phosphate Label Image" ], "set_id": "36140639-e7a8-43bc-83e2-469430af9d1a", "id": "b5a8f590-413c-440b-9908-ad84f627824a", "effective_time": "20240213", "version": "9", "openfda": { "application_number": [ "M012" ], "brand_name": [ "Guaifenesin and Codeine Phosphate" ], "generic_name": [ "GUAIFENESIN AND CODEINE PHOSPHATE" ], "manufacturer_name": [ "A-S Medication Solutions" ], "product_ndc": [ "50090-1428" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "GUAIFENESIN", "CODEINE PHOSPHATE" ], "rxcui": [ "995868" ], "spl_id": [ "b5a8f590-413c-440b-9908-ad84f627824a" ], "spl_set_id": [ "36140639-e7a8-43bc-83e2-469430af9d1a" ], "package_ndc": [ "50090-1428-0" ], "original_packager_product_ndc": [ "0121-0775" ], "nui": [ "N0000193956", "N0000008867", "N0000009560" ], "pharm_class_epc": [ "Expectorant [EPC]" ], "pharm_class_pe": [ "Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]" ], "unii": [ "495W7451VQ", "GSL05Y1MN6" ] } } ] }