OMEPRAZOLE- omeprazole magnesium capsule, delayed release

omeprazole by

Drug Labeling and Warnings

omeprazole by is a Otc medication manufactured, distributed, or labeled by CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each capsule)

Omeprazole delayed-release capsule 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 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 (1-888-222-1222).

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 capsule with a glass of water before eating in the morning
• take every day for 14 days
• do not take more than 1 capsule a day
• do not use for more than 14 days unless directed by your doctor
• swallow whole. Do not chew or crush capsules.
•   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
• FDA approved dissolution test specifications differ from USP

Inactive ingredients

FD&C yellow # 6, ferric oxide, gelatin, glyceryl monostearate, hypromellose, magnesium stearate, meglumine, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, shellac, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

CVS Health®

Compare to the active ingredient in Prilosec OTC®

MINI CAPSULES

Treats FREQUENT Heartburn!

TRIPLE PACK

3 X 14 COUNT BOTTLES INSIDE

Omeprazole

DELAYED-RELEASE CAPSULES, 20 mg

Acid reducer

See current Drug Facts

Actual Size

24 HOUR

42 MINI CAPSULES

Three 14-day courses of treatment

May take 1 to 4 days for full effect

INGREDIENTS AND APPEARANCE

OMEPRAZOLE 
omeprazole magnesium capsule, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-271
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OMEPRAZOLE MAGNESIUM (UNII: 426QFE7XLK) (OMEPRAZOLE - UNII:KG60484QX9)	OMEPRAZOLE	20 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FERRIC OXIDE RED (UNII: 1K09F3G675)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MEGLUMINE (UNII: 6HG8UB2MUY)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SHELLAC (UNII: 46N107B71O)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Characteristics
Color	WHITE, ORANGE	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	24S
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-271-03	3 in 1 CARTON	04/01/2025
1	NDC: 51316-271-01	14 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA216096	04/01/2025

Labeler - CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED (062312574)