PRILOSEC (Page 13 of 13)

Package/Label Display Panel – 10 mg Capsules

NDC 0186-0606-31

PRILOSEC^®

(omeprazole)

30 Delayed-Release Capsules

10 mg

Dispense the accompanying Medication Guide to each patient.

Rx only

AstraZeneca

Package/Label Display Panel – 20 mg Capsules

NDC 0186-0742-31

PRILOSEC^®

(omeprazole)

30 Delayed-Release Capsules

20 mg

Dispense the accompanying Medication Guide to each patient.

Rx only

AstraZeneca

Package/Label Display Panel – 40 mg Capsules

NDC 0186-0743-31

PRILOSEC^®

(omeprazole)

30 Delayed-Release Capsules

40 mg

Dispense the accompanying Medication Guide to each patient.

Rx only

AstraZeneca

Package/Label Display Panel – 2.5 mg Oral Suspension

NDC 0186-0625-01

PRILOSEC^®

(omeprazole magnesium)

For Delayed-Release Oral Suspension

2.5 mg

This packet contains 2.8 mg of omeprazole magnesium which is equivalent

to 2.5 mg of omeprazole as delayed-release granules.

Dispense the enclosed Medication Guide to each patient.

Rx only

Mfd for: AstraZeneca LP, Wilmington, DE 19850

By: AstraZeneca AB, Sodertalje, Sweden

Product of Sweden

AstraZeneca

Package/Label Display Panel — 10 mg Oral Suspension

NDC 0186-0610-01

PRILOSEC^®

(omeprazole magnesium)

For Delayed-Release Oral Suspension

10 mg

This packet contains 11.2 mg of omeprazole magnesium which is equivalent

to 10 mg of omeprazole as delayed-release granules.

Dispense the enclosed Medication Guide to each patient.

Rx only

Mfd for: AstraZeneca LP, Wilmington, DE 19850

By: AstraZeneca AB, Sodertalje, Sweden

Product of Sweden

AstraZeneca

PRILOSEC omeprazole magnesium capsule, delayed release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0186-0606 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OMEPRAZOLE MAGNESIUM (OMEPRAZOLE) OMEPRAZOLE 10 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE MANNITOL SODIUM LAURYL SULFATE GELATIN FD&C BLUE NO. 1 FD&C RED NO. 40 D&C RED NO. 28 TITANIUM DIOXIDE HYPROMELLOSES HYDROXYPROPYL CELLULOSE (TYPE H) FD&C BLUE NO. 2 FERROSOFERRIC OXIDE BUTYL ALCOHOL D&C RED NO. 7 D&C YELLOW NO. 10

Product Characteristics Color PURPLE (apricot and amethyst) Score no score Shape CAPSULE (opaque, hard gelatin) Size 14mm Flavor Imprint Code 606;prilosec10 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0186-0606-31 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None 2 NDC:0186-0606-82 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019810 11/15/1995

PRILOSEC omeprazole magnesium capsule, delayed release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0186-0742 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OMEPRAZOLE MAGNESIUM (OMEPRAZOLE) OMEPRAZOLE 20 mg

Inactive Ingredients Ingredient Name Strength HYPROMELLOSES ANHYDROUS LACTOSE MANNITOL SODIUM LAURYL SULFATE GELATIN FD&C BLUE NO. 1 FD&C RED NO. 40 D&C RED NO. 28 TITANIUM DIOXIDE BUTYL ALCOHOL FD&C BLUE NO. 2 D&C RED NO. 7 D&C YELLOW NO. 10 FERROSOFERRIC OXIDE HYDROXYPROPYL CELLULOSE (TYPE H)

Product Characteristics Color PURPLE (amethyst) Score no score Shape CAPSULE (opaque, hard gelatin) Size 17mm Flavor Imprint Code 742;prilosec20 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0186-0742-31 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None 2 NDC:0186-0742-82 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019810 10/01/1990

PRILOSEC omeprazole magnesium capsule, delayed release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0186-0743 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OMEPRAZOLE MAGNESIUM (OMEPRAZOLE) OMEPRAZOLE 40 mg

Inactive Ingredients Ingredient Name Strength HYDROXYPROPYL CELLULOSE (TYPE H) HYPROMELLOSES ANHYDROUS LACTOSE MANNITOL SODIUM LAURYL SULFATE GELATIN FD&C BLUE NO. 1 FD&C BLUE NO. 2 D&C RED NO. 28 D&C YELLOW NO. 10 TITANIUM DIOXIDE BUTYL ALCOHOL D&C RED NO. 7 FD&C RED NO. 40 FERROSOFERRIC OXIDE

Product Characteristics Color PURPLE (apricot and amethyst) Score no score Shape CAPSULE (opaque, hard gelatin) Size 19mm Flavor Imprint Code 743;prilosec40 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0186-0743-31 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None 2 NDC:0186-0743-68 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE None 3 NDC:0186-0743-82 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019810 06/08/1998

PRILOSEC omeprazole magnesium granule, delayed release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0186-0625 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OMEPRAZOLE MAGNESIUM (OMEPRAZOLE) OMEPRAZOLE 2.5 mg

Inactive Ingredients Ingredient Name Strength GLYCERYL MONOSTEARATE HYDROXYPROPYL CELLULOSE (TYPE H) HYPROMELLOSES MAGNESIUM STEARATE METHACRYLIC ACID POLYSORBATE 80 SODIUM HYDROXIDE TALC TRIETHYL CITRATE XANTHAN GUM ANHYDROUS CITRIC ACID ANHYDROUS DEXTROSE ALCOHOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0186-0625-01 30 GRANULE, DELAYED RELEASE in 1 CARTON None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022056 02/09/2002

PRILOSEC omeprazole magnesium granule, delayed release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0186-0610 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OMEPRAZOLE MAGNESIUM (OMEPRAZOLE) OMEPRAZOLE 10 mg

Inactive Ingredients Ingredient Name Strength HYDROXYPROPYL CELLULOSE (TYPE H) HYPROMELLOSES MAGNESIUM STEARATE TALC TRIETHYL CITRATE ANHYDROUS CITRIC ACID XANTHAN GUM ANHYDROUS DEXTROSE GLYCERYL MONOSTEARATE METHACRYLIC ACID POLYSORBATE 80 SODIUM HYDROXIDE ALCOHOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0186-0610-01 30 GRANULE, DELAYED RELEASE in 1 CARTON None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022056 02/09/2002

Labeler — AstraZeneca Pharmaceuticals LP (938368834)

Registrant — AstraZeneca PLC (230790719)

Revised: 12/2016 AstraZeneca Pharmaceuticals LP