OMEPRAZOLE- omeprazole magnesium tablet, delayed release 
P & L Development, LLC

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OMEPRAZOLE MAGNESIUM DELAYED-RELEASE TABLETS

ACTIVE INGREDIENT

(in each tablet)

Omeprazole delayed-release tablet 20 mg

(equivalent to 20.6 mg omeprazole magnesium)

Purpose

Acid reducer

Use

Warnings

Allergy alert: Do not use if you are allergic to omeprazole

Do not use if you have:

These may be signs of a serious condition. See your doctor.

Ask a doctor before use if you have:

Ask a doctor or pharmacist before use if you are

taking a prescription drug.

Acid reducers may interact with certain drugs.

Stop use and ask a doctor if:

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

 In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

14-Day Course of Treatment

Repeated 14-Day Courses (if needed)

Other information

Inactive ingredients

acetyl tributyl citrate, colloidal silicon dioxide, corn starch, croscarmellose sodium, hydroxypropyl cellulose, hypromellose 2910, magnesium stearate, methacrylic acid copolymer type C, microcrystalline cellulose, polyethylene glycol 400, polyethylene glycol 3350, polyethylene glycol 8000, polyvinyl alcohol, red iron oxide, sucrose, talc, titanium dioxide, triethyl citrate

Tips for Managing Heartburn

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Prilosec OTC®*

Omeprazole Delayed-Release Tablets 20 mg 

 ACID REDUCER

Treats FREQUENT Heartburn 24 Hr

One-14-Day Course of Treatment

14 Tablets

Omeprazole

Omeprazole Tablets

PACKAGE LABEL, PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Prilosec OTC®*

Omeprazole Delayed-Release Tablets 20 mg

ACID REDUCER 

SWALLOW - DO NOT CHEW

Treats FREQUENT Heartburn 24 HR

14 Tablets 

One-14-Day Course of Treatment

Coated with Wildberry Flavor

Omeprazole

Ompeprazole Wildberry Tablets


OMEPRAZOLE 
omeprazole magnesium tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-297
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEPRAZOLE MAGNESIUM (UNII: 426QFE7XLK) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20.6 mg
Inactive Ingredients
Ingredient NameStrength
ACETYLTRIBUTYL CITRATE (UNII: 0ZBX0N59RZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorredScoreno score
ShapeOVAL (capsule-shaped) Size13mm
FlavorImprint Code OM;20
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59726-297-141 in 1 CARTON06/02/202012/31/2025
114 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:59726-297-282 in 1 CARTON06/02/202012/31/2025
214 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:59726-297-423 in 1 CARTON06/02/202012/31/2025
314 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20658206/02/202012/31/2025
OMEPRAZOLE 
omeprazole magnesium tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-737
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEPRAZOLE MAGNESIUM (UNII: 426QFE7XLK) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20.6 mg
Inactive Ingredients
Ingredient NameStrength
ACETYLTRIBUTYL CITRATE (UNII: 0ZBX0N59RZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
DEXTROSE (UNII: IY9XDZ35W2)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TRIACETIN (UNII: XHX3C3X673)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Product Characteristics
ColorpurpleScoreno score
ShapeOVALSize13mm
FlavorBERRYImprint Code OM;20
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59726-737-141 in 1 CARTON06/02/202012/31/2025
114 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:59726-737-282 in 1 CARTON06/02/202012/31/2025
214 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:59726-737-423 in 1 CARTON06/02/202012/31/2025
314 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20658206/02/202012/31/2025
Labeler - P & L Development, LLC (800014821)

Revised: 4/2023
Document Id: 374eac2d-56c9-4973-acb1-710620384e70
Set id: c9d30986-304a-408a-a48c-eee1ed0bf301
Version: 16
Effective Time: 20230420
 
P & L Development, LLC