11534-187 : Butalbital, Acetaminophen and Caffeine Oral Capsule

NDC:	11534-187
Labeler:	Sunrise Pharmaceutical, Inc
Product Type:	Human Prescription Drug
Drug Name:	Butalbital, Acetaminophen and Caffeine
Dosage Form:	Oral Capsule
Application #:	ANDA207118
Rev. Date:	Jan 10, 2017
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:	N;26
Shapes:	Capsule
Colors:	Blue / 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:

• 11534-187-01: 100 CAPSULE IN 1 BOTTLE (11534‑187‑01)
• 11534-187-04: 500 CAPSULE IN 1 BOTTLE (11534‑187‑04)

Active Ingredients:

• Acetaminophen
• Caffeine
• Butalbital

Inactive Ingredients:

• Fd&c Blue No. 1
• Fd&c Red No. 40
• Gelatin
• Cellulose, Microcrystalline
• Stearic Acid
• Talc
• Titanium Dioxide

Pharmaceutical Classes:

• Barbiturate [EPC]
• Barbiturates [CS]
• Central Nervous System Stimulant [EPC]
• Central Nervous System Stimulation [PE]
• Methylxanthine [EPC]
• Xanthines [CS]

Related Products:

Based on records with the same trade name.

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• 0591-2640 Apap 300 mg / Butalbital 50 mg / Caffeine 40 mg Oral Capsule by Watson Pharma, Inc.
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• 10135-628 Butalbital, Acetaminophen and Caffeine Oral Capsule by Marlex Pharmaceuticals Inc
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