NDC 70518-2167 Prilosec Otc

Omeprazole Magnesium

NDC Product Code 70518-2167

NDC Code: 70518-2167

Proprietary Name: Prilosec Otc What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Omeprazole Magnesium What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
PINK (C48328)
Shape: OVAL (C48345)
Size(s):
15 MM
Imprint(s):
P
Score: 1

NDC Code Structure

  • 70518 - Remedyrepack Inc.

NDC 70518-2167-0

Package Description: 30 TABLET, DELAYED RELEASE in 1 BLISTER PACK

NDC Product Information

Prilosec Otc with NDC 70518-2167 is a a human over the counter drug product labeled by Remedyrepack Inc.. The generic name of Prilosec Otc is omeprazole magnesium. The product's dosage form is tablet, delayed release and is administered via oral form.

Labeler Name: Remedyrepack Inc.

Dosage Form: Tablet, Delayed Release - A solid dosage form which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Prilosec Otc Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • OMEPRAZOLE MAGNESIUM 20.6 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • 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)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Remedyrepack Inc.
Labeler Code: 70518
FDA Application Number: NDA021229 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 06-28-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Prilosec Otc Product Label Images

Prilosec Otc Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

Dist. by Procter & Gamble, Cincinnati, OH 45202Product of Sweden

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 more days a week)
  • Not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Allergy Alert

Do not use if you are allergic to omeprazole

Otc - Do Not Use

  • Do not use if you have:trouble or pain swallowing food, vomiting with blood, or bloody or black stoolsheartburn with
  • Lightheadedness, sweating or dizzinesschest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadednessfrequent
  • Chest pain
  • These may be signs of a serious condition. See your doctor.

Otc - Ask Doctor

  • Ask a doctor before use if you havehad heartburn over 3 months. This may be a sign of a more serious condition.frequent wheezing, particularly with heartburnunexplained weight lossnausea or vomitingstomach pain

Otc - Ask Doctor/Pharmacist

  • Ask a doctor or pharmacist before use if you are taking
  • Warfarin, clopidogrel, or cilostazol (blood-thinning medicines)prescription antifungal or anti-yeast medicinesdiazepam (anxiety medicine)digoxin (heart medicine)tacrolimus or mycophenolate mofetil (immune system medicines)prescription antiretrovirals (medicines for HIV infection)methotrexate (arthritis medicine)

Otc - Stop Use

  • Stop use and ask a doctor ifyour heartburn continues or worsensyou need to take this product for more than 14 daysyou need to take more than 1 course of treatment every 4 monthsyou get diarrhea

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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 olderthis product is to be used once a day (every 24 hours), every day for 14 daysit may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours
  • 14-Day Course of Treatmentswallow 1 tablet with a glass of water before eating in
  • The morningtake every day for 14 daysdo not take more than 1 tablet a daydo not use for more than 14 days unless directed by your doctorswallow whole. Do not chew or crush tablets.
  • Repeated 14-Day Courses (if needed)you may repeat a 14-day course every 4 monthsdo not take for more than 14 days or more often than every 4 months unless directed by a doctorchildren 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 usekeep 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

* Please review the disclaimer below.