DailyMed - OMEPRAZOLE- omeprazole magnesium capsule, delayed release

NDC Code(s): 51316-271-01, 51316-271-03
Packager: CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 2, 2025

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Active ingredient (in each capsule)
Omeprazole delayed-release capsule 20 mg (equivalent to 20.6 mg omeprazole magnesium)

Omeprazole delayed-release capsule 20 mg (equivalent to 20.6 mg omeprazole magnesium)
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Purpose
Acid reducer

Acid reducer
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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

•

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

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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 ...

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

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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

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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).

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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 ...

•

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

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take every day for 14 days

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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.

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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 ...

•

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

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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 ...

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
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Questions or comments?
1-800-719-9260

1-800-719-9260
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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 ...

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

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INGREDIENTS AND APPEARANCE

Product Information

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	RxCUI	RxNorm NAME	RxTTY
1	198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN
2	198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD
3	198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY

Label: OMEPRAZOLE- omeprazole magnesium capsule, delayed release

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Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use if you have:

Ask a doctor before use if you have:

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if:

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

	NDC
1	51316-271-01
2	51316-271-03

Label: OMEPRAZOLE- omeprazole magnesium capsule, delayed release

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use if you have:

Ask a doctor before use if you have:

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if:

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

OMEPRAZOLE- omeprazole magnesium capsule, delayed release

Number of versions: 1

OMEPRAZOLE- omeprazole magnesium capsule, delayed release

OMEPRAZOLE- omeprazole magnesium capsule, delayed release

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OMEPRAZOLE- omeprazole magnesium capsule, delayed release

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