55312-217 : Apap 650 mg 8 Hr Extended Release Tablet

NDC:	55312-217
Labeler:	Western Family Foods Inc
Product Type:	Human OTC Drug
Drug Name:	Acetaminophen 8 Hour
Dosage Form:	Oral Tablet, Film Coated, Extended Release
Application #:	ANDA075077
Rev. Date:	Nov 30, 2005

Appearance:

Markings:	L217
Shapes:	Capsule
Colors:	Red
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:

• 55312-217-71: 1 BOTTLE IN 1 CARTON (55312‑217‑71) > 50 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE

Active Ingredients:

• Acetaminophen

Inactive Ingredients:

• Carnauba Wax
• Silicon Dioxide
• Croscarmellose Sodium
• Hypromelloses
• Magnesium Stearate
• Maltodextrin
• Cellulose, Microcrystalline
• Polyethylene Glycols
• Polysorbate 80
• Povidones
• Stearic Acid
• Titanium Dioxide

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