68071-4657 : Butalbital, Acetaminophen and Caffeine Oral Tablet

NDC:	68071-4657
Labeler:	Nucare Pharmaceuticals, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Butalbital, Acetaminophen and Caffeine
Dosage Form:	Oral Tablet
Application #:	ANDA089175
Rev. Date:	Aug 28, 2015
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:	MIA;110
Shapes:	Oval
Colors:	White
Size (mm):	14
Segments: *	2
* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 2 indicates a scored pill which can be broken into 2 equal pieces.

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:

• 68071-4657-3: 30 TABLET IN 1 BOTTLE (68071‑4657‑3)

Active Ingredients:

• Butalbital
• Acetaminophen
• Caffeine

Inactive Ingredients:

• Cellulose, Microcrystalline
• Croscarmellose Sodium
• Crospovidone
• Povidone, Unspecified
• Silicon Dioxide
• Starch, Corn
• Stearic Acid /

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

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