PRILOSEC OTC- omeprazole magnesium tablet, delayed release 
The Procter & Gamble Manufacturing Company

----------

Prilosec OTC ®
omeprazole magnesium delayed-release tablets 20 mg / acid reducer

Drug Facts

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:

If an allergic reaction occurs, stop use and seek medical help right away.

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 prescription 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

Other information

Inactive ingredients

glyceryl monostearate, hydroxypropyl cellulose, hypromellose, iron oxide, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, paraffin, polyethylene glycol 6000, polysorbate 80, polyvinylpyrrolidone, sodium stearyl fumarate, starch, sucrose, talc, titanium dioxide, triethyl citrate

Questions?

1-800-289-9181

Safety Feature - Do not use if tablet blister unit is open or torn.

Dist. by Procter & Gamble, Cincinnati, OH 45202

Product of Sweden

PRINCIPAL DISPLAY PANEL - 14 Tablet Carton

See current Drug Facts

NDC 37000-455-03

Treats FREQUENT Heartburn! 24 HR

PrilosecOTC®

omeprazole delayed-release tablets

20 mg / acid reducer

28 TABLETS
Two 14-day courses of treatment

May take 1 to 4 days for full effect

455

PRILOSEC OTC 
omeprazole magnesium tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-455
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
STARCH, RICE (UNII: 4DGK8B7I3S)  
POVIDONE K60 (UNII: SZR7Z3Q2YH)  
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
PARAFFIN (UNII: I9O0E3H2ZE)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorpinkScoreno score
ShapeOVALSize15mm
FlavorImprint Code P
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-455-011 in 1 POUCH; Type 0: Not a Combination Product07/14/2003
2NDC:37000-455-021 in 1 CARTON07/14/2003
214 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:37000-455-032 in 1 CARTON07/14/2003
31 in 1 CARTON
314 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:37000-455-043 in 1 CARTON07/14/2003
41 in 1 CARTON
414 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:37000-455-051 in 1 BLISTER PACK; Type 0: Not a Combination Product07/14/2003
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02122907/14/2003
Labeler - The Procter & Gamble Manufacturing Company (004238200)
Registrant - AstraZeneca AB (Sweden) (876516568)

Revised: 7/2024
Document Id: 1cd51d5d-87f0-1a29-e063-6394a90a1e7a
Set id: 77ed80a2-a482-4838-ac55-4865b5c31d9f
Version: 14
Effective Time: 20240709
 
The Procter & Gamble Manufacturing Company