PRILOSEC OTC- omeprazole magnesium tablet, delayed release

Prilosec OTC by

Drug Labeling and Warnings

Prilosec OTC by is a Otc medication manufactured, distributed, or labeled by REMEDYREPACK INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 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
• 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

• 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

• 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

SPL UNCLASSIFIED SECTION

Dist. by Procter & Gamble, Cincinnati, OH 45202

Product of Sweden

PRINCIPAL DISPLAY PANEL

DRUG: Prilosec OTC

GENERIC: omeprazole magnesium

DOSAGE: TABLET, DELAYED RELEASE

ADMINSTRATION: ORAL

NDC: 70518-2167-0

COLOR: pink

SHAPE: OVAL

SCORE: No score

SIZE: 15 mm

IMPRINT: P

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

• OMEPRAZOLE MAGNESIUM 20.6mg in 1

INACTIVE INGREDIENT(S):

• GLYCERYL MONOSTEARATE
• POLYSORBATE 80
• SODIUM STEARYL FUMARATE
• POLYETHYLENE GLYCOL 6000
• SUCROSE
• TALC
• TITANIUM DIOXIDE
• FERRIC OXIDE RED
• HYDROXYPROPYL CELLULOSE
• HYPROMELLOSES
• PARAFFIN
• CELLULOSE, MICROCRYSTALLINE
• MAGNESIUM STEARATE
• TRIETHYL CITRATE

INGREDIENTS AND APPEARANCE

PRILOSEC OTC 
omeprazole magnesium tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70518-2167(NDC:37000-455)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OMEPRAZOLE MAGNESIUM (UNII: 426QFE7XLK) (OMEPRAZOLE - UNII:KG60484QX9)	OMEPRAZOLE	20.6 mg

Inactive Ingredients
Ingredient Name	Strength
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)

Product Characteristics
Color	pink	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code	P
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70518-2167-0	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	06/28/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021229	06/28/2019

Labeler - REMEDYREPACK INC. (829572556)