50090-0006 : Tylenol With Codeine Oral Tablet

NDC:	50090-0006
Labeler:	A-s Medication Solutions LLC
Product Type:	Human Prescription Drug
Drug Name:	Tylenol With Codeine
Dosage Form:	Oral Tablet
Application #:	ANDA085055
Rev. Date:	Aug 17, 1977
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:	McNEIL;TYLENOL;CODEINE;3
Shapes:	Round
Colors:	White
Size (mm):	11
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:

• 50090-0006-2: 20 TABLET IN 1 BOTTLE (50090‑0006‑2)

Active Ingredients:

• Acetaminophen
• Codeine Phosphate

Inactive Ingredients:

• Powdered Cellulose
• Magnesium Stearate
• Sodium Metabisulfite
• Starch, Corn

Pharmaceutical Classes:

• Full Opioid Agonists [MoA]
• Opioid Agonist [EPC]

Related Products:

Based on records with the same trade name.

• 54569-0024 Tylenol #3 Oral Tablet by A-s Medication Solutions LLC
• 50458-513 Tylenol #3 Oral Tablet by Janssen Pharmaceuticals, Inc.
• 50458-515 Tylenol #4 Oral Tablet by Janssen Pharmaceuticals, Inc.
• 55154-1908 Tylenol #3 Oral Tablet by Cardinal Health
• 55154-1916 Tylenol #4 Oral Tablet by Cardinal Health
• 55289-048 Tylenol #3 Oral Tablet by Pd-rx Pharmaceuticals, Inc.

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