cvs pharmacy, inc. omeprazole drug facts

cvs pharmacy, inc. omeprazole drug facts
SPL v2
SPL
SPL Set ID 8edfcc08-a14e-4579-bd44-045267de5b79
Route
oral
Published
Effective Date 2025-04-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
omeprazole (20 mg)
Inactive Ingredients
fd&c yellow no. 6 ferric oxide red gelatin, unspecified glyceryl monostearate hypromellose, unspecified magnesium stearate meglumine polyethylene glycol, unspecified polysorbate 80 shellac sodium lauryl sulfate talc titanium dioxide triethyl citrate

Identifiers & Packaging

Pill Appearance
Imprint: 24S Shape: capsule Color: white Color: orange Size: 14 mm Score: 1
Marketing Status
anda active Since 2025-04-01

Purpose

Acid reducer

Description

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


Medication Information

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.

Purpose

Acid reducer

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

Description

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

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
Questions Or Comments?

1-800-719-9260

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.

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).

Active Ingredient (in Each Capsule)

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

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
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

Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug. Acid reducers may interact with certain prescription drugs.


Structured Label Content

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.

Purpose

Acid reducer

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 (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 (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

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
Questions Or Comments? (Questions or comments?)

1-800-719-9260

Do Not Use If You Have: (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.

Stop Use and Ask A Doctor If: (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (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).

Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

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

Ask A Doctor Before Use If You Have: (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
Package/label Principal Display Panel (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

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking a prescription drug. Acid reducers may interact with certain prescription drugs.


Advanced Ingredient Data


Raw Label Data

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