0187-0108 : Tussicaps Oral Capsule, Extended Release

NDC:	0187-0108
Labeler:	Valeant Pharmaceuticals North America LLC
Product Type:	Human Prescription Drug
Drug Name:	Tussicaps
Dosage Form:	Oral Capsule, Extended Release
Application #:	ANDA077273
Rev. Date:	Sep 2, 2011
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:	ECR;HP;CP;10;8
Shapes:	Capsule
Colors:	White
Size (mm):	20
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:

• 0187-0108-01: 100 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE (0187‑0108‑01)
• 0187-0108-20: 20 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE (0187‑0108‑20)

Active Ingredients:

• Hydrocodone
• Chlorpheniramine

Inactive Ingredients:

• Butyl Alcohol
• Alcohol
• Gelatin
• Ferric Oxide Red
• D&c Black No. 2
• Isopropyl Alcohol
• Cellulose, Microcrystalline
• Propylene Glycol
• Water
• Shellac
• Ammonia
• Titanium Dioxide
• D&c Yellow No. 10
• Fd&c Blue No. 1
• Fd&c Blue No. 2
• Fd&c Red No. 40

Pharmaceutical Classes:

• Opioid Agonist [EPC]
• Opioid Agonists [MoA]
• Histamine H1 Receptor Antagonists [MoA]
• Histamine-1 Receptor Antagonist [EPC]

Related Products:

Based on records with the same trade name.

• 0187-0054 Tussicaps Oral Capsule, Extended Release by Valeant Pharmaceuticals North America LLC
• 0095-0054 Tussicaps Half-strength (Chlorpheniramine 4 mg / Hydrocodone Bitartrate 5 mg) 12 Hr Extended Release Capsule by Ecr Pharmaceuticals
• 0095-0108 Tussicaps (Chlorpheniramine 8 mg / Hydrocodone Bitartrate 10 mg) 12 Hr Extended Release Capsule by Ecr Pharmaceuticals
• 54868-5957 Tussicaps (Chlorpheniramine 8 mg / Hydrocodone Bitartrate 10 mg) 12 Hr Extended Release Capsule by Physicians Total Care, Inc.

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