DailyMed - CAREONE OMEPRAZOLE- omeprazole tablet, delayed release

NDC Code(s): 41520-802-01, 41520-802-03
Packager: American Sales Company

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

Drug Label Information

Updated April 14, 2025

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Active ingredient (in each tablet)
Omeprazole 20 mg

Omeprazole 20 mg
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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

•

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 (1-800-222-1222).

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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 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.

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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

•

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

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Inactive ingredients
benzyl alcohol, carmine, carnauba wax, FD&C blue #2/indigo carmine aluminum lake, flavor, hypromellose, hypromellose acetate succinate, lactose monohydrate, menthol, modified starch ...

benzyl alcohol, carmine, carnauba wax, FD&C blue #2/indigo carmine aluminum lake, flavor, hypromellose, hypromellose acetate succinate, lactose monohydrate, menthol, modified starch, monoethanolamine, polyethylene glycol 3350, sodium lauryl sulfate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, sucralose, talc, titanium dioxide, triacetin, 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
CAREone™ Compare to Prilosec OTC® OMEPRAZOLE - Delayed Release Tablets 20mg - Acid Reducer - Treats Frequent Heartburn! 3 BOTTLES INSIDE - SWALLOW – DO NOT CHEW - Wildberry Mint Coated Tablet - Actual ...

CAREone™

Compare to Prilosec OTC®

OMEPRAZOLE

Delayed Release Tablets 20mg

Acid Reducer

Treats Frequent Heartburn!

3 BOTTLES INSIDE

SWALLOW – DO NOT CHEW

Wildberry Mint Coated Tablet

Actual Size

24HR

42 TABLETS

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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Published Date (What is this?)	Version	Files
Apr 18, 2025	3 (current)	download
Apr 5, 2021	2	download

	RxCUI	RxNorm NAME	RxTTY
1	402014	omeprazole 20 MG Delayed Release Oral Tablet	PSN
2	402014	omeprazole 20 MG Delayed Release Oral Tablet	SCD
3	402014	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Tablet	SY

Label: CAREONE OMEPRAZOLE- omeprazole tablet, 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	41520-802-01
2	41520-802-03

Label: CAREONE OMEPRAZOLE- omeprazole tablet, 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

CAREONE OMEPRAZOLE- omeprazole tablet, delayed release

Number of versions: 2

CAREONE OMEPRAZOLE- omeprazole tablet, delayed release

CAREONE OMEPRAZOLE- omeprazole tablet, delayed release

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CAREONE OMEPRAZOLE- omeprazole tablet, delayed release

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.