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

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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

  • treats frequent heartburn (occurs 2 or moredays a week)
  • not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Warnings

Allergy Alert:

  • Do not use if you are allergic to omeprazole
  • Omeprazole may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash

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

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 shoulder pain with shortness of 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 a prescription drug.
Acid reducers may interact with certain prescription drugs.

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
  • you develop a rash or joint pain

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

  • for adults 18 years of age and older
  • this product is to be used once a day (every 24 hours), every day for 14 days
  • it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours

    14-Day Course of Treatment
    • swallow 1 tablet with a glass of water before eating in the morning
    • take every day for 14 days
    • do not take more than 1 tablet a day
    • do not use for more than 14 days unless directed by your doctor
    • swallow whole. Do not chew or crush tablets.
    Repeated 14-Day Courses (if needed)
    • you may repeat a 14-day course every 4 months
    • do not take for more than 14 days or more often than every 4 months unless directed by a doctor
  • children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition.

Other information

  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • store at 20-25°C (68-77°F) and protect from moisture

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

Prilosec OTC®

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)
Establishment
NameAddressID/FEIBusiness Operations
Minakem Dunkerque Production277412599api manufacture(37000-455)
Establishment
NameAddressID/FEIBusiness Operations
Dishman Pharmaceuticals and Chemicals Ltd915628142api manufacture(37000-455)
Establishment
NameAddressID/FEIBusiness Operations
Anderson Brecon Inc.053217022pack(37000-455)
Establishment
NameAddressID/FEIBusiness Operations
Sonoco Display and Packaging129850751pack(37000-455)

Revised: 8/2023
 
The Procter & Gamble Manufacturing Company