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 The Procter & Gamble Manufacturing Company. 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.
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

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

Keep out of reach of children.

OVERDOSAGE

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, crush, or suck 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 to 25°C (68 to 77°F) and protect from moisture

Inactive ingredients

acetyl tributyl citrate, colloidal silicon dioxide, corn starch, croscarmellose sodium, dextrose, FD&C blue #2, FD&C red #40, flavor, hydroxypropyl cellulose, hypromellose 2910, magnesium stearate, methacrylic acid copolymer type c, microcrystalline cellulose, polyethylene glycol 400, polyethylene glycol 3350, polyethylene glycol 8000, polysorbate 80, polyvinyl alcohol, propylene glycol, sucralose, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

Questions?

1-800-289-9181

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Safety Feature - Do not use if tablet blister unit is open or torn.

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Dist. by Procter & Gamble,
Cincinnati, OH 45202

PRINCIPAL DISPLAY PANEL - 42 Tablet Carton

NEW FORMULA

SAME ACTIVE INGREDIENT.

SEE CURRENT DRUG FACTS.

NDC: 84126-301-42

Treats FREQUENT Heartburn! 24 HR

Prilosec OTC ®

omeprazole delayed-release tablets

20 mg / acid reducer

SWALLOW - DO NOT CHEW

Three 14-day courses of treatment

May take 1 to 4 days for full effect.

WILDBERRY Coated Tablet

42 TABLETS

INGREDIENTS AND APPEARANCE

PRILOSEC OTC 
omeprazole magnesium tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84126-301
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
ACETYL TRIBUTYL CITRATE (UNII: 0ZBX0N59RZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DEXTROSE (UNII: IY9XDZ35W2)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYVINYL ALCOHOL (UNII: 532B59J990)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
POLYETHYLENE GLYCOL 8000000 (UNII: 8EIY1IHX76)

Product Characteristics
Color	purple	Score	score with uneven pieces
Shape	OVAL	Size	13mm
Flavor	BERRY	Imprint Code	24
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84126-301-14	1 in 1 CARTON	06/03/2025
1		14 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 84126-301-42	3 in 1 CARTON	06/03/2025
2		14 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA206582	06/03/2025

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Registrant - The Procter & Gamble Manufacturing Company (004238200)