0113-0058 : Good Sense Omeprazole and Sodium Bicarbonate Oral Capsule, Gelatin Coated

NDC:	0113-0058
Labeler:	L. Perrigo Company
Product Type:	Human OTC Drug
Drug Name:	Good Sense Omeprazole and Sodium Bicarbonate
Dosage Form:	Oral Capsule, Gelatin Coated
Application #:	ANDA201361
Rev. Date:	Jun 19, 2017

Appearance:

Markings:	732
Shapes:	Oval
Colors:	White
Size (mm):	23
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:

• 0113-0058-03: 3 BOTTLE IN 1 CARTON (0113‑0058‑03) > 14 CAPSULE, GELATIN COATED IN 1 BOTTLE

Active Ingredients:

• Omeprazole
• Sodium Bicarbonate

Inactive Ingredients:

• Fd&c Blue No. 1
• Fd&c Red No. 40
• Gelatin
• Polysorbate 80
• Sodium Lauryl Sulfate
• Sodium Stearyl Fumarate
• Titanium Dioxide

Pharmaceutical Classes:

• Cytochrome P450 2C19 Inhibitors [MoA]
• Increased Large Intestinal Motility [PE]
• Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
• Osmotic Activity [MoA]
• Osmotic Laxative [EPC]
• Proton Pump Inhibitor [EPC]
• Proton Pump Inhibitors [MoA]

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