57664-419 : Asa 356.4 mg / Caffeine 30 mg / Dihydrocodeine Bitartrate 16 mg Oral Capsule

NDC:	57664-419
Labeler:	Caraco Pharmaceutical Laboratories, Ltd
Product Type:	Human Prescription Drug
Drug Name:	Aspirin, Caffeine, and Dihydrocodeine Bitartrate
Dosage Form:	Oral Capsule
Application #:	NDA011483
Rev. Date:	Oct 1, 2012
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:	CP;419
Shapes:	Capsule
Colors:	Blue / Gray
Size (mm):	19
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:

• 57664-419-88: 100 CAPSULE IN 1 BOTTLE (57664‑419‑88)

Active Ingredients:

• Aspirin
• Caffeine
• Dihydrocodeine Bitartrate

Inactive Ingredients:

• Alginic Acid
• Cellulose, Microcrystalline
• D&c Red No. 28
• Fd&c Blue No. 1
• Gelatin
• Ferrosoferric Oxide
• Stearic Acid
• Titanium Dioxide

Pharmaceutical Classes:

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

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