0591-2641 : Apap 300 mg / Butalbital 50 mg / Caffeine 40 mg / Codeine Phosphate 30 mg Oral Capsule

NDC:	0591-2641
Labeler:	Watson Pharma, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
Dosage Form:	Oral Capsule
Application #:	ANDA076560
Rev. Date:	Jul 29, 2013
CSA Schedule:	CIII (US) [1]

^[1] Schedule III / IIIN Controlled Substance: Has a potential for abuse less than substances in Schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence. (i.e. Products containing not more than 90 milligrams of Codeine per dosage unit [such as Tylenol with Codeine], other narcotics such as Buprenorphine (Suboxone), and Schedule IIIN non-narcotics such as Didrex, Ketamine, Phendimetrazine, and Anabolic Steroids). More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:

Markings:	FIORICET;CODEINE
Shapes:	Capsule
Colors:	Gray / Blue
Size (mm):	22
Segments: *	1
* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

• 0591-2641-01: 100 CAPSULE IN 1 BOTTLE, PLASTIC (0591‑2641‑01)

Active Ingredients:

• Butalbital
• Acetaminophen
• Caffeine
• Codeine Phosphate

Inactive Ingredients:

• D&c Yellow No. 10
• Fd&c Blue No. 1
• Fd&c Red No. 40
• Fd&c Yellow No. 6
• Gelatin
• Cellulose, Microcrystalline
• Sodium Lauryl Sulfate
• Stearic Acid
• Talc

Pharmaceutical Classes:

• Barbiturate [EPC]
• Barbiturates [CS]
• Central Nervous System Stimulant [EPC]
• Central Nervous System Stimulation [PE]
• Full Opioid Agonists [MoA]
• Methylxanthine [EPC]
• Opioid Agonist [EPC]
• Xanthines [CS]

Related Products:

Based on records with the same trade name.

• 0591-3220 Apap 325 mg / Butalbital 50 mg / Caffeine 40 mg / Codeine Phosphate 30 mg Oral Capsule by Watson Laboratories, Inc.
• 0054-0650 Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Oral Capsule by Hikma Pharmaceuticals USA Inc.
• 0054-3000 Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Oral Capsule by Hikma Pharmaceuticals USA Inc.
• 0603-2553 Apap 325 mg / Butalbital 50 mg / Caffeine 40 mg / Codeine Phosphate 30 mg Oral Capsule by Qualitest Pharmaceuticals
• 0722-6670 Apap 325 mg / Butalbital 50 mg / Caffeine 40 mg / Codeine Phosphate 30 mg Oral Capsule by Nexgen Pharma, Inc.
• 0722-7028 Apap 300 mg / Butalbital 50 mg / Caffeine 40 mg / Codeine Phosphate 30 mg Oral Capsule by Nexgen Pharma, Inc.
• 51991-073 Apap 325 mg / Butalbital 50 mg / Caffeine 40 mg / Codeine Phosphate 30 mg Oral Capsule by Breckenridge Pharmaceutical, Inc.
• 54868-5162 Apap 325 mg / Butalbital 50 mg / Caffeine 40 mg / Codeine Phosphate 30 mg Oral Capsule by Physicians Total Care, Inc.
• 63629-3152 Apap 325 mg / Butalbital 50 mg / Caffeine 40 mg / Codeine Phosphate 30 mg Oral Capsule by Bryant Ranch Prepack
• 68258-2012 Apap 325 mg / Butalbital 50 mg / Caffeine 40 mg / Codeine Phosphate 30 mg Oral Capsule by Dispensing Solutions, Inc.
• 71335-0194 Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Oral Capsule by Bryant Ranch Prepack
• 71335-0653 Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Oral Capsule by Bryant Ranch Prepack
• 72162-1591 Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Oral Capsule by Bryant Ranch Prepack
• 79739-6670 Acetaminophen 325 mg / Butalbital 50 mg / Caffeine 40 mg / Codeine Phosphate 30 mg Oral Capsule by Lgm Pharma Solutions LLC
• 79739-7028 Acetaminophen 300 mg / Butalbital 50 mg / Caffeine 40 mg / Codeine Phosphate 30 mg Oral Capsule by Lgm Pharma Solutions, LLC

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