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

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Prilosec OTC

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

Do not use if you are allergic to omeprazole

Do not use if you have:

  • trouble or pain swallowing food, vomiting with blood, or bloody or black stools
  • heartburn with lightheadedness, sweating or dizziness
  • chest pain or shoulderpain with shortnessof breath; sweating; pain spreading to arms, neck, or shoulders; or lightheadedness
  • frequent chest pain

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

Ask a doctor before use if you have

  • had heartburn over 3 months. This may be a sign of a more serious condition.
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain

Ask a doctor or pharmacist before use if you are taking

  • warfarin, clopidogrel, or cilostazol (blood-thinning medicines)
  • prescription antifungal or anti-yeast medicines
  • diazepam (anxiety medicine)
  • digoxin (heart medicine)
  • tacrolimus or mycophenolate mofetil (immune system medicines)
  • prescription antiretrovirals (medicines for HIV infection)
  • methotrexate (arthritis medicine)

Stop use and ask a doctor if

  • your heartburn continues or worsens
  • you need to take this product for more than 14 days
  • you need to take more than 1 course of treatment every 4 months
  • you get diarrhea

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

FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, flavor, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, mica, microcrystalline cellulose, polyethylene glycol 6000, polysorbate 80, polyvinylpyrrolidone, saccharin sodium, sodium stearyl fumarate, starch, sucrose, talc, titanium dioxide, triethyl citrate

Questions?

1-800-289-9181

Dist. by Procter & Gamble,
Cincinnati, OH 45202

Product of Sweden

PRINCIPAL DISPLAY PANEL - 14 Tablet Carton

Treats FREQUENT Heartburn!

Occurring 2 Or More Days A Week

NDC 37000-459-02

Prilosec OTC ®

omeprazole delayed-release tablets

20 mg / acid reducer

SWALLOW - DO NOT CHEW

14 TABLETS

One 14-day course of treatment

Coated with

Wildberry Flavor

459 Prilosec Wild Berry

PRILOSEC OTC 
omeprazole magnesium tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-459
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEPRAZOLE MAGNESIUM (UNII: 426QFE7XLK) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICA (UNII: V8A1AW0880)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorpurpleScoreno score
ShapeOVALSize15mm
FlavorBERRYImprint Code P
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-459-011 in 1 POUCH; Type 0: Not a Combination Product08/15/2012
2NDC:37000-459-0214 in 1 CARTON08/15/2012
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:37000-459-032 in 1 CARTON08/15/201212/01/2022
314 in 1 CARTON
31 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:37000-459-043 in 1 CARTON08/15/2012
414 in 1 CARTON
41 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:37000-459-051 in 1 BLISTER PACK; Type 0: Not a Combination Product08/15/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02122908/15/2012
Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 2/2021
Document Id: bb262789-0749-bfe2-e053-2a95a90ab2fa
Set id: 35a79458-79f6-44d6-b74c-b4f4aaf0dde0
Version: 10
Effective Time: 20210212
 
The Procter & Gamble Manufacturing Company