| These highlights do not include all the information needed to use ASCOMP with Codeine safely and effectively. See full prescribing information for ASCOMP with Codeine. ASCOMP with Codeine (butalbital, aspirin, caffeine, and codeine phosphate, USP) capsules, for oral use, CIII Initial U.S. Approval: 1990 | Bryant Ranch Prepack | 20260527 | 16 |
| 52617668-acc3-65cd-e063-6294a90ab919 | Redpharm Drug | 20260522 | 1 |
| ff77a959-c77a-4911-8f7c-e2a3e24a6305 | Bryant Ranch Prepack | 20260515 | 103 |
| f308fd07-f004-42de-963d-426b268bba93 | Bryant Ranch Prepack | 20260514 | 103 |
| Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only | Bryant Ranch Prepack | 20260506 | 8 |
| Acetaminophen and Codeine Phosphate Tablets, USP CIII | Proficient Rx LP | 20260501 | 2 |
| Codeine-Guaifenesin Oral Solution | Method Pharmaceuticals, LLC | 20260401 | 16 |
| Codeine-Guaifenesin | A-S Medication Solutions | 20260331 | 5 |
| 1fe39679-fd58-4d2c-ba61-49d492a2b087 | REMEDYREPACK INC. | 20260330 | 12 |
| 4c966d73-77c6-4514-954e-57aa06a080c6 | REMEDYREPACK INC. | 20260330 | 11 |
| 879db1b5-6365-4151-9879-80d8a2a3cd8a | Bryant Ranch Prepack | 20260323 | 103 |
| e73b17c4-9f24-4b32-8920-61c58c40a714 | Bryant Ranch Prepack | 20260323 | 103 |
| 79377617-686b-4640-b2b8-e1358cf82358 | Eywa Pharma Inc | WES Pharma Inc. | 20260306 | 8 |
| ACETAMINOPHEN AND CODEINE PHOSPHATE ORAL SOLUTION USP, CV | Genus Lifesciences Inc. | 20260225 | 4 |
| These highlights do not include all the information needed to use ASCOMP with Codeine safely and effectively. See full prescribing information for ASCOMP with Codeine. ASCOMP with Codeine (butalbital, aspirin, caffeine, and codeine phosphate, USP) capsules, for oral use, CIII Initial U.S. Approval: 1990 | Breckenridge Pharmaceutical, Inc. | LGM Pharma Solutions, LLC | 20260209 | 13 |
| Acetaminophen and Codeine Phosphate Tablets USP CIII | REMEDYREPACK INC. | 20260203 | 7 |
| Acetaminophen and Codeine Phosphate Tablets USP CIII | A-S Medication Solutions | 20260123 | 18 |
| Acetaminophen and Codeine Phosphate Tablets USP CIII | A-S Medication Solutions | 20260122 | 12 |
| Acetaminophen and Codeine Phosphate Tablets USP CIII | A-S Medication Solutions | 20260122 | 12 |
| Acetaminophen and Codeine Phosphate Tablets, USP CIII (300 mg/15 mg, 300 mg/30 mg and 300 mg/60 mg) Rx Only | ST. MARY'S MEDICAL PARK PHARMACY | 20260121 | 1 |
| These highlights do not include all the information needed to use CODEINE SULFATE TABLETS safely and effectively. See full prescribing information for CODEINE SULFATE TABLETS. CODEINE SULFATE tablets, USP, for oral use CII Initial U.S. Approval: 1950 | Lannett Company, Inc. | 20260116 | 29 |
| These highlights do not include all the information needed to use BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE capsules safely and effectively. See full prescribing information for BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE. BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE capsules, USP, for oral use Initial U.S. Approval: 1990 | Amneal Pharmaceuticals of New York, LLC | Jerome Stevens Pharmaceuticals, Inc. | 20260115 | 8 |
| Acetaminophen and Codeine Phosphate Tablets USP CIII | Preferred Pharmaceuticals Inc. | 20260114 | 6 |
| Acetaminophen and Codeine Phosphate Tablets USP CIII | Preferred Pharmaceuticals Inc. | 20260114 | 6 |
| These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII Initial U.S. Approval: 1992 | Actavis Pharma, Inc. | 20260109 | 38 |
| These highlights do not include all the information needed to use BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULES safely and effectively. See full prescribing information for BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULES. BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULES for oral use, CIII Initial U.S. Approval: 1992 | Bryant Ranch Prepack | 20260108 | 10 |
| These highlights do not include all the information needed to use PROMETHAZINE and PHENYLEPHRINE HCL AND CODEINE PHOSPHATE ORAL SOLUTION safely and effectively. See full prescribing information for PROMETHAZINE and PHENYLEPHRINE HCL AND CODEINE PHOSPHATE ORAL SOLUTION. PROMETHAZINE and PHENYLEPHRINE HCL and CODEINE PHOSPHATE oral solution, CV Initial U.S. Approval: 1952 | Amneal Pharmaceuticals LLC | Amneal Pharmaceuticals, LLC | 20260108 | 36 |
| These highlights do not include all the information needed to use BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULES safely and effectively. See full prescribing information for BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULES. BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE capsules, for oral use, CIII Initial U.S. Approval: 1992 | Hikma Pharmaceuticals USA Inc. | West-Ward Columbus Inc. | 20260102 | 6 |
| Acetaminophen and Codeine Phosphate Tablets USP CIII | SpecGx LLC | 20251223 | 50 |
| Acetaminophen and Codeine Phosphate Tablets, USP CIII | Aurolife Pharma, LLC | 20251223 | 23 |
| These highlights do not include all the information needed to use CODEINE SULFATE TABLETS safely and effectively. See full prescribing information for CODEINE SULFATE TABLETS. CODEINE SULFATE tablets, for oral use CII Initial U.S. Approval: 1950 | Hikma Pharmaceuticals USA Inc. | West-Ward Columbus Inc. | 20251222 | 25 |
| These highlights do not include all the information needed to use PROMETHAZINE HCL AND CODEINE PHOSPHATE ORAL SOLUTION safely and effectively. See full prescribing information for PROMETHAZINE HCL AND CODEINE PHOSPHATE ORAL SOLUTION. PROMETHAZINE HCL and CODEINE PHOSPHATE oral solution, CV Initial U.S. Approval: 1952 | Cosette Pharmaceuticals, Inc. | Tris Pharma Inc | 20251218 | 1 |
| HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PROMETHAZINE HCL AND CODEINE PHOSPHATE ORAL SOLUTION safely and effectively. See full prescribing information for PROMETHAZINE HCL AND CODEINE PHOSPHATE ORAL SOLUTION. PROMETHAZINE HCL and CODEINE PHOSPHATE oral solution, CV Initial U.S. Approval: 1952 | Cranbury Pharmaceuticals, LLC | 20251212 | 13 |
| These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII Initial U.S. Approval: 1992 | Actavis Pharma, Inc. | 20251210 | 10 |
| Acetaminophen and Codeine Phosphate Tablets, USP CIII | Elite Laboratories, Inc. | 20251201 | 17 |
| Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only | Amneal Pharmaceuticals LLC | 20251201 | 46 |
| These highlights do not include all the information needed to use Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP safely and effectively. See full prescribing information for Butalbital, Aspirin, Caffe i ne, and Codeine Phosphate Capsules, USP . B utalbital, A spirin, C affeine, and C odeine P hosphate C apsules, USP for oral use, CIII Initial U.S. Approval: 1990 | LGM PHARMA SOLUTIONS, LLC | 20251101 | 15 |
| Acetaminophen and Codeine Phosphate Tablets, USP CIII (300 mg/15 mg, 300 mg/30 mg and 300 mg/60 mg) Rx Only | Bryant Ranch Prepack | 20251028 | 1 |
| Acetaminophen and Codeine Phosphate Tablets, USP CIII (300 mg/15 mg, 300 mg/30 mg and 300 mg/60 mg) Rx Only | Bryant Ranch Prepack | 20251022 | 1 |
| Guaifenesin and Codeine Phosphate | Cardinal Health 107, LLC | 20251003 | 4 |
| Acetaminophen and Codeine Phosphate Tablets, USP CIII (300 mg/15 mg, 300 mg/30 mg and 300 mg/60 mg) Rx Only | REMEDYREPACK INC. | 20250925 | 2 |
| Duratuss AC | Poly Pharmaceuticals, Inc. | 20250909 | 1 |
| 682ef287-647a-4d89-9bbf-75907ebd10f2 | Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM | 20250817 | 2 |
| Guaifenesin and Codeine Phosphate | Preferred Pharmaceuticals Inc. | 20250616 | 3 |
| Acetaminophen and Codeine Phosphate Tablets USP CIII | Bryant Ranch Prepack | 20250605 | 1 |
| 0065-PROMETHAZINE HCL AND CODEINE PHOSPHATE ORAL SOLUTION HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PROMETHAZINE HCL AND CODEINE PHOSPHATE ORAL SOLUTION safely and effectively. See full prescribing information for PROMETHAZINE HCL AND CODEINE PHOSPHATE ORAL SOLUTION. PROMETHAZINE HCL and CODEINE PHOSPHATE oral solution, CV Initial U.S. Approval: 1952 | ATLANTIC BIOLOGICALS CORP. | 20250604 | 3 |
| 7ab27392-9c6e-4ec3-85e7-06b43fcab3b1 | Preferred Pharmaceuticals Inc. | 20250602 | 1 |
| Acetaminophen and Codeine Phosphate Tablets, USP CIII | Advanced Rx of Tennessee, LLC | 20250602 | 1 |
| Acetaminophen and Codeine Phosphate Tablets, USP CIII (300 mg/15 mg, 300 mg/30 mg and 300 mg/60 mg) Rx Only | Preferred Pharmaceuticals Inc. | 20250602 | 1 |
| Acetaminophen and Codeine Phosphate Tablets, USP CIII Rx Only | Advanced Rx of Tennessee, LLC | 20250602 | 1 |
| Codeine-Guaifenesin | Westminster Pharmaceuticals, LLC | 20250508 | 6 |
| ACETAMINOPHEN AND CODEINE | Direct_Rx | 20250429 | 2 |
| Acetaminophen and Codeine 300/30mg tabs | RedPharm Drug, Inc. | 20250409 | 5 |
| Acetaminophen and Codeine Phosphate Tablets, USP CIII (300 mg/15 mg, 300 mg/30 mg and 300 mg/60 mg) Rx Only | NuCare Pharmaceuticals, Inc. | 20250402 | 1 |
| ACETAMINOPHEN AND CODEINE | Direct_Rx | 20250219 | 7 |
| Acetaminophen and Codeine Phosphate Tablets, USP CIII | NuCare Pharmaceuticals, Inc. | 20250219 | 1 |
| Acetaminophen and Codeine Phosphate Tablets USP CIII | NuCare Pharmaceuticals,Inc. | 20250204 | 5 |
| Acetaminophen and Codeine Phosphate | Direct_Rx | 20250122 | 2 |
| 1e932a34-a7d3-e4ec-e063-6294a90a25b1 | NuCare Pharmaceuticals, Inc. | 20250114 | 3 |
| ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP (300 mg/15 mg, 300 mg/30 mg, 300 mg/60 mg) CIII Rx only | Aphena Pharma Solutions - Tennessee, LLC | 20250108 | 5 |
| Acetaminophen and Codeine Phosphate Tablets, USP CIII (300 mg/30 mg) Rx Only | Proficient Rx LP | 20250101 | 1 |
| ddba3d1e-2829-be3c-e053-2995a90a7650 | NuCare Pharmaceuticals,Inc. | 20241226 | 2 |
| ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP (300 mg/15 mg, 300 mg/30 mg, 300 mg/60 mg) CIII Rx only | Quality Care Products, LLC | 20241216 | 3394 |
| Acetaminophen and Codeine Phosphate Tablets USP CIII | Coupler LLC | 20241107 | 2 |
| Acetaminophen and Codeine Phosphate Oral Solution USP CV | PAI Holdings, LLC dba PAI Pharma | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma | 20241004 | 31 |
| Codeine-Guaifenesin | Proficient Rx LP | 20241001 | 2 |
| These highlights do not include all the information needed to use BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULES safely and effectively. See full prescribing information for BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULES. BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULES for oral use, CIII Initial U.S. Approval: 1992 | Breckenridge Pharmaceutical, Inc. | LGM Pharma Solutions, LLC | 20240912 | 11 |
| Guaifenesin and Codeine Phosphate | PAI Holdings, LLC | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma | 20240906 | 11 |
| Acetaminophen and Codeine Phosphate Tablets USP CIII | Bryant Ranch Prepack | 20240822 | 1012 |
| Acetaminophen and Codeine Phosphate Tablets USP CIII | Bryant Ranch Prepack | 20240822 | 9 |
| Acetaminophen and Codeine Phosphate Tablets, USP CIII | Bryant Ranch Prepack | 20240809 | 8 |
| Acetaminophen and Codeine Phosphate Tablets, USP CIII | Bryant Ranch Prepack | 20240809 | 101 |
| 50e8fd6f-8cde-4c61-e054-00144ff88e88 | RedPharm Drug, Inc. | 20240808 | 7 |
| 1e01f923-38c1-9b59-e063-6394a90a22f1 | NuCare Pharmaceuticals, Inc. | 20240724 | 1 |
| Acetaminophen and Codeine Phosphate Oral Solution USP CV | Redpharm Drug, Inc | 20240702 | 2 |
| ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP (300 mg/30 mg) CIII Rx only | Proficient Rx LP | 20240701 | 9 |
| Codeine-Guaifenesin Oral Solution | NuCare Pharmaceuticals,Inc. | 20240620 | 3 |
| Acetaminophen and Codeine Phosphate Tablets, USP CIII | NuCare Pharmaceuticals,Inc. | 20240618 | 4 |
| Acetaminophen and Codeine Phosphate Tablets, USP CIII | NuCare Pharmaceuticals,Inc. | 20240614 | 4 |
| Acetaminophen and Codeine Phosphate Tablets, USP CIII | NuCare Pharmaceuticals,Inc. | 20240612 | 7 |
| Acetaminophen and Codeine Phosphate Tablets USP CIII | NuCare Pharmaceuticals,Inc. | 20240610 | 5 |
| acetaminophen w/cod | RedPharm Drug | RedPharm Drug, Inc. | 20240603 | 7 |
| Acetaminophen and Codeine Phosphate Tablets, USP CIII (300 mg/15 mg, 300 mg/30 mg and 300 mg/60 mg) Rx Only | Strides Pharma Science Limited | Strides Pharma Global Pte. Ltd. | Strides Pharma, Inc | 20240520 | 1 |
| Codeine-Guaifenesin | ATLANTIC BIOLOGICALS CORP. | UNIT DOSE SOLUTIONS | 20240508 | 3 |
| HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PROMETHAZINE HCL AND CODEINE PHOSPHATE ORAL SOLUTION safely and effectively. See full prescribing information for PROMETHAZINE HCL AND CODEINE PHOSPHATE ORAL SOLUTION. PROMETHAZINE HCL and CODEINE PHOSPHATE oral solution, CV Initial U.S. Approval: 1952 | Bryant Ranch Prepack | 20240416 | 104 |
| These highlights do not include all the information needed to use BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULES safely and effectively. See full prescribing information for BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULES. BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULES for oral use, CIII Initial U.S. Approval: 1992 | Bryant Ranch Prepack | 20240404 | 101 |
| Codeine-Guaifenesin Oral Solution | Bryant Ranch Prepack | 20240322 | 100 |
| MAR-COF ® CG Expectorant | Marnel Pharmaceuticals, LLC | Marnel Pharmaceuticals LLC | 20240315 | 5 |
| Guaifenesin and Codeine Phosphate | A-S Medication Solutions | 20240213 | 9 |
| These highlights do not include all the information needed to use TUXARIN ER™ safely and effectively. See full prescribing information for TUXARIN ER. TUXARIN ER (codeine phosphate and chlorpheniramine maleate) extended-release tablets, for oral use, CIII Initial U.S. Approval: 1985 | Mainpointe Pharmaceuticals | LGM Pharma Solutions | 20240110 | 6 |
| ebdbc975-4e0e-4b83-8cf4-f29da829113a | Bryant Ranch Prepack | 20240109 | 6 |
| Acetaminophen and Codeine Phosphate Tablets USP CIII | Clinical Solutions Wholesale, LLC | 20240109 | 3 |
| Acetaminophen and Codeine Phosphate Tablets USP CIII | Clinical Solutions Wholesale, LLC | 20240108 | 5 |
| Acetaminophen and Codeine Phosphate Tablets USP CIII | RPK Pharmaceuticals, Inc. | 20230911 | 2 |
| Acetaminophen and Codeine Phosphate Oral Solution USP CV | RPK Pharmaceuticals, Inc. | 20230607 | 5 |
| Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only | RPK Pharmaceuticals, Inc. | 20230607 | 5 |
| Codeine-Guaifenesin | NuCare Pharmaceuticals,Inc. | 20230607 | 2 |
| Promethazine/Codeine | Direct_Rx | 20230602 | 1 |
| ACETAMINOPHEN AND CODEINE | DIRECT RX | 20230329 | 15 |
| Guaifenesin and Codeine Phosphate Oral Solution, USP CV 100 mg/10 mg per 5 mL SUGAR FREE, DYE FREE, ALCOHOL FREE | NuCare Pharmaceuticals,Inc. | 20230216 | 1 |
| These highlights do not include all the information needed to use PROMETHAZINE HCL AND CODEINE PHOSPHATE ORAL SOLUTION safely and effectively. See full prescribing information for PROMETHAZINE HCL AND CODEINE PHOSPHATE ORAL SOLUTION. PROMETHAZINE HCL and CODEINE PHOSPHATE oral solution, CV Initial U.S. Approval: 1952 | QUAGEN PHARMACEUTICALS LLC | 20230215 | 5 |
| ACETAMINOPHEN AND CODEINE | Direct_Rx | 20230112 | 2 |
| Acetaminophen and Codeine Phosphate Oral Solution, USP | Akorn | Akorn Operating Company LLC | 20221115 | 34 |
| Drug Facts | Akorn Operating Company LLC | 20221014 | 8 |
| Acetaminophen and Codeine Phosphate Tablets USP CIII | ST. MARY'S MEDICAL PARK PHARMACY | 20221011 | 1 |
| Acetaminophen and Codeine Phosphate Tablets USP CIII | NuCare Pharmaceuticals,Inc. | 20220719 | 1 |
| Acetaminophen and Codeine Phosphate Tablets, USP CIII | Proficient Rx LP | 20220401 | 6 |
| Acetaminophen and Codeine Phosphate Tablets, USP CIII Rx only | Bryant Ranch Prepack | 20211227 | 4 |
| These highlights do not include all the information needed to use PROMETHAZINE HCL AND CODEINE PHOSPHATE ORAL SOLUTION safely and effectively. See full prescribing information for PROMETHAZINE HCL AND CODEINE PHOSPHATE ORAL SOLUTION. PROMETHAZINE HCL and CODEINE PHOSPHATE oral solution, CV Initial U.S. Approval: 1952 | ATLANTIC BIOLOGICALS CORP. | 20210623 | 1 |
| 469aec61-ccb9-4a09-82e6-23081a7b3a0d | A-S Medication Solutions | 20210614 | 3 |
| These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII. Initial U.S. Approval: 1992 | LGM Pharma Solutions, LLC | 20210614 | 2 |
| Virtussin AC | A-S Medication Solutions | 20210302 | 1 |
| These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII Initial U.S. Approval: 1992 | LGM PHARMA SOLUTIONS, LLC | 20210301 | 4 |
| These highlights do not include all the information needed to use FIORICET with CODEINE safely and effectively. See full prescribing information for FIORICET with CODEINE. FIORICET ® with CODEINE (butalbital, acetaminophen, caffeine, and codeine phosphate) Capsules, for oral use, CIII Initial U.S. Approval: 1992 | Actavis Pharma, Inc. | 20210301 | 11 |
| Codeine-Guaifenesin Oral Solution | ATLANTIC BIOLOGICALS CORP. | 20210126 | 4 |
| These highlights do not include all the information needed to use PROMETHAZINE WITH CODEINE ORAL SOLUTION safely and effectively. See full prescribing information for PROMETHAZINE WITH CODEINE ORAL SOLUTION Initial U.S. Approval:1952 | ATLANTIC BIOLOGICALS CORP. | 20210125 | 2 |
| Acetaminophen and Codeine Phosphate Oral Solution, USP 120 mg/12 mg per 5 mL | ATLANTIC BIOLOGICALS COPR. | 20210112 | 6 |
| G Tussin AC | The Generic Pharmaceutical Company | 20210112 | 4 |
| PROMETHAZINE WITH CODEINE ORAL SOLUTION | RedPharm Drug, Inc. | Unit Dose Solutions, Inc. | 20210101 | 3 |
| These highlights do not include all the information needed to use [enter drug name] safely and effectively. See full prescribing information for [enter drug name]. Initial U.S. Approval: [enter year] | Proficient Rx LP | 20210101 | 4 |