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Prilosec OTC by Procter & Gamble Manufacturing Company

Dosage form: tablet, delayed release
Ingredients: omeprazole magnesium 20.6mg
Labeler: Procter & Gamble Manufacturing Company
NDC Code: 37000-455

Prilosec
OTC®
omeprazole magnesium delayed-
release tablets 20.6 mg / acid reducer

Drug Facts

Active ingredient (in each tablet)

Omeprazole magnesium delayed-release tablet 20.6 mg (equivalent to 20 mg omeprazole).

Purpose

Acid reducer

Use
  • treats frequent heartburn (occurs 2 or more days 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

Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools.
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.
  • 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
  • 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 (immune system medicine)
  • prescription antiretrovirals (medicines for HIV infection)

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

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

Dist. by Procter & Gamble, Cincinnati, OH 45202

Product of Sweden

PRINCIPAL DISPLAY PANEL - 14 Tablet Carton

NDC 37000-455-02

Prilosec
OTC
®
omeprazole magnesium delayed-
release tablets 20.6 mg / acid reducer

14 TABLETS
One 14-day course of treatment

Treats FREQUENT Heartburn!
Occurring
2 Or More Days A Week

PRILOSEC OTC 
omeprazole magnesium tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-455
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
omeprazole magnesium (omeprazole) omeprazole magnesium20.6 mg
Inactive Ingredients
Ingredient NameStrength
GLYCERYL MONOSTEARATE 
HYDROXYPROPYL CELLULOSE 
HYPROMELLOSES 
FERRIC OXIDE RED 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
PARAFFIN 
POLYETHYLENE GLYCOL 6000 
POLYSORBATE 80 
SODIUM STEARYL FUMARATE 
SUCROSE 
TALC 
TITANIUM DIOXIDE 
TRIETHYL CITRATE 
Product Characteristics
ColorPINKScoreno score
ShapeOVALSize15mm
FlavorImprint CodeP
Contains    
Packaging
#Item CodePackage Description
1NDC:37000-455-011 TABLET, DELAYED RELEASE (TABLET) in 1 POUCH
2NDC:37000-455-021 BLISTER PACK (BLISTER PACK) in 1 CARTON
214 TABLET, DELAYED RELEASE (TABLET) in 1 BLISTER PACK
3NDC:37000-455-032 CARTON (CARTON) in 1 CARTON
31 BLISTER PACK (BLISTER PACK) in 1 CARTON
314 TABLET, DELAYED RELEASE (TABLET) in 1 BLISTER PACK
4NDC:37000-455-043 CARTON (CARTON) in 1 CARTON
41 BLISTER PACK (BLISTER PACK) in 1 CARTON
414 TABLET, DELAYED RELEASE (TABLET) in 1 BLISTER PACK
5NDC:37000-455-051 TABLET, DELAYED RELEASE (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02122907/14/2003
Labeler - Procter & Gamble Manufacturing Company (004238200)
Establishment
NameAddressID/FEIOperations
The Procter & Gamble Manufacturing Company (Swing Road)003237963PACK, REPACK, LABEL

Revised: 06/2011
 
Procter & Gamble Manufacturing Company

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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