0591-3546 : Asa 325 mg / Butalbital 50 mg / Caffeine 40 mg / Codeine Phosphate 30 mg Oral Capsule

NDC:	0591-3546
Labeler:	Watson Laboratories, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Butalbital, Aspirin, Caffeine and Codeine Phosphate
Dosage Form:	Oral Capsule
Application #:	NDA019429
Rev. Date:	Jul 12, 2007
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:	WATSON;3546
Shapes:	Capsule
Colors:	Blue / Yellow
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.

The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

• 0591-3546-01: 100 CAPSULE IN 1 BOTTLE (0591‑3546‑01)
• 0591-3546-05: 500 CAPSULE IN 1 BOTTLE (0591‑3546‑05)

Active Ingredients:

• Aspirin
• Butalbital
• Caffeine
• Codeine Phosphate

Inactive Ingredients:

• Cellulose, Microcrystalline
• Starch, Corn
• Talc
• D&c Yellow No. 10
• Fd&c Blue No. 1
• Fd&c Red No. 3
• Fd&c Yellow No. 6
• Gelatin
• Titanium Dioxide
• Ferric Oxide Red

Pharmaceutical Classes:

• Full Opioid Agonists [MoA]
• Opioid Agonist [EPC]
• Barbiturate [EPC]
• Barbiturates [Chemical/Ingredient]
• Central Nervous System Stimulant [EPC]
• Central Nervous System Stimulation [PE]
• Methylxanthine [EPC]
• Xanthines [Chemical/Ingredient]
• Cyclooxygenase Inhibitors [MoA]
• Decreased Prostaglandin Production [PE]
• Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
• Nonsteroidal Anti-inflammatory Drug [EPC]

Related Products:

Based on records with the same trade name.

• 0527-1312 Asa 325 mg / Butalbital 50 mg / Caffeine 40 mg / Codeine Phosphate 30 mg Oral Capsule by Lannett Company, Inc.
• 50090-0103 Butalbital, Aspirin, Caffeine and Codeine Phosphate Oral Capsule by A-s Medication Solutions LLC
• 50564-507 Asa 325 mg / Butalbital 50 mg / Caffeine 40 mg / Codeine Phosphate 30 mg Oral Capsule by Jerome Stevens Pharmaceuticals
• 54569-0337 Butalbital, Aspirin, Caffeine and Codeine Phosphate Oral Capsule by A-s Medication Solutions LLC
• 54868-1037 Asa 325 mg / Butalbital 50 mg / Caffeine 40 mg / Codeine Phosphate 30 mg Oral Capsule by Physicians Total Care, Inc.
• 63629-2952 Asa 325 mg / Butalbital 50 mg / Caffeine 40 mg / Codeine Phosphate 30 mg Oral Capsule by Bryant Ranch Prepack
• 68308-312 Butalbital, Aspirin, Caffeine, and Codeine Phosphate Oral Capsule by Mayne Pharma Inc.
• 69238-1993 Butalbital, Aspirin, Caffeine and Codeine Phosphate Oral Capsule by Amneal Pharmaceuticals LLC

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