Omeprazole Delayed-release Tablets, 20 Mg/acid Reducer

Omeprazole Delayed-release Tablets, 20 Mg/acid Reducer
SPL v5
SPL
SPL Set ID 9c856d3a-e38f-4006-a43a-ec1a9fa0f057
Route
ORAL
Published
Effective Date 2022-11-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Omeprazole (20 mg)
Inactive Ingredients
Silicon Dioxide Crospovidone Glyceryl Monostearate Hypromellose 2910 (5 Mpa.s) Magnesium Stearate Polyethylene Glycol 6000 Polysorbate 80 Sodium Hydroxide Sodium Lauryl Sulfate Talc Triethyl Citrate Hydroxypropyl Cellulose Sucrose Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A Cellulose, Microcrystalline Ferric Oxide Red Lactose Monohydrate Starch, Corn Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: H;O9 Shape: oval Color: pink Size: 14 mm Score: 1
Marketing Status
ANDA Active Since 2020-03-25

Description

Omeprazole delayed-release tablet, 20 mg (equivalent to 20.6 mg omeprazole magnesium USP)

Purpose

Acid reducer


Medication Information

Purpose

Acid reducer

Description

Omeprazole delayed-release tablet, 20 mg (equivalent to 20.6 mg omeprazole magnesium USP)

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 allergy reaction occurs, stop use and seek medical help 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 14 days unless directed by your doctor

•  swallow whole. Do not chew or crush 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.

Questions?

1-888-588-1418

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


colloidal silicon dioxide, crospovidone, glyceryl monostearate, hypromellose, hydroxypropyl cellulose, iron oxide red, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, silicified microcrystalline cellulose, sodium hydroxide, sodium lauryl sulphate, starlac (contains lactose monohydrate and corn starch), sugar spheres (contains sucrose and corn starch), talc, titanium dioxide, triethyl citrate.

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.

Principal Display Panel

 

NDC 69230-318-35

See Current Drug Facts

Compare to Prilosec OTC ®*

Omeprazole

Delayed-Release Tablets

20 mg

Acid Reducer

Treats FREQUENT Heartburn!

Occuring 2 Or More Days A Week

24 HR

One 14-day course of treatment

May take 1 to 4 days for full effect

14 TABLETS

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.

Active Ingredient (in Each Tablet)

Omeprazole delayed-release tablet, 20 mg

(equivalent to 20.6 mg omeprazole magnesium USP)



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.






Structured Label Content

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



Purpose

Acid reducer

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 allergy reaction occurs, stop use and seek medical help 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 14 days unless directed by your doctor

•  swallow whole. Do not chew or crush 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.

Questions?

1-888-588-1418

Other Information (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 (Inactive ingredients)


colloidal silicon dioxide, crospovidone, glyceryl monostearate, hypromellose, hydroxypropyl cellulose, iron oxide red, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, silicified microcrystalline cellulose, sodium hydroxide, sodium lauryl sulphate, starlac (contains lactose monohydrate and corn starch), sugar spheres (contains sucrose and corn starch), talc, titanium dioxide, triethyl citrate.

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.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

 

NDC 69230-318-35

See Current Drug Facts

Compare to Prilosec OTC ®*

Omeprazole

Delayed-Release Tablets

20 mg

Acid Reducer

Treats FREQUENT Heartburn!

Occuring 2 Or More Days A Week

24 HR

One 14-day course of treatment

May take 1 to 4 days for full effect

14 TABLETS

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.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Omeprazole delayed-release tablet, 20 mg

(equivalent to 20.6 mg omeprazole magnesium USP)



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

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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