Omeprazole Delayed Release Tablets 20 Mg

Omeprazole Delayed Release Tablets 20 Mg
SPL v3
SPL
SPL Set ID 921bf750-9dd7-42ff-82bb-043b03f0fe69
Route
ORAL
Published
Effective Date 2023-11-06
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Omeprazole (20 mg)
Inactive Ingredients
Glyceryl Monostearate Silicon Dioxide Crospovidone, Unspecified Hydroxypropyl Cellulose, Unspecified Hypromellose, Unspecified Magnesium Stearate Methacrylic Acid And Ethyl Acrylate Copolymer Microcrystalline Cellulose Polyethylene Glycol 400 Polyethylene Glycol 6000 Polysorbate 80 Ferric Oxide Red Dimethicone Sodium Stearyl Fumarate Starch, Corn Sucrose Talc Titanium Dioxide Triethyl Citrate

Identifiers & Packaging

Pill Appearance
Imprint: 91 Shape: oval Color: pink Size: 14 mm Score: 1
Marketing Status
ANDA Active Since 2025-08-12

Description

Active ingredient (in each tablet)                                          Omeprazole, USP 20 mg  (equivalent to 20.6 mg omeprazole magnesium)

Purpose

Purpose  Acid reducer


Medication Information

Purpose

Purpose 

Acid reducer





Description

Active ingredient (in each tablet)                                          Omeprazole, USP 20 mg  (equivalent to 20.6 mg omeprazole magnesium)

Use(s)

Uses

• 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







Storage

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


Warnings

Warnings

Allergy alert: 

  • Do not use if you are allergic to Omeprazole
  • Omeprazole may cause severe skin reactions. Symptoms include:
    • skin reddening
    • blisters
    • rash
    If an allergic reaction occurs, stop use and seek medical attention right away.


Directions

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 1 tablet a day
  • do not use for 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.
Do Not Use

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.





Active Ingredient(s)

Active ingredient (in each tablet)                                         

Omeprazole, USP 20 mg 

(equivalent to 20.6 mg omeprazole magnesium)



Inactive Ingredients

Inactive ingredients 

colloidal silicone dioxide, crospovidone, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol 400, polyethylene glycol 6000, polysorbate 80, red iron oxide, simethicone, sodium stearyl fumarate, starch, sucrose, talc, titanium dioxide, triethyl citrate





Questions Or Comments

Questions or comments? Call 1-877-376-4271 (weekdays 9 AM to 5 PM)



Tips for Managing Heartburn 


• Do not lie flat or bend over after eating. 

• Do not wear tight-fitting clothing around the stomach.

• Do not eat before bedtime. 

• Raise the head of your bed. 

• Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine,     alcohol and certain fruits and vegetables.      

• Eat slowly and do not eat big meals.

• If overweight, lose weight. 

• Quit smoking. 



Manufactured for:

Time-Cap Labs, Inc. 

7 Michael Avenue, 

Farmingdale, 

NY 11735, USA



Manufactured by: 

Marksans Pharma Ltd.

Plot No. L-82, L-83

Verna Indl. Estate

Verna, Goa-403722, India  





Pregnancy/breastfeeding

If pregnant or breast-feeding, ask a health professional before use.

Principal Display Panel

NDC: 25000-091-76

Omeprazole Delayed-Release Tablets 20 mg 

14's count Carton 







NDC: 25000-091-76

Omeprazole Delayed-Release Tablets 20 mg 

14's count Label 







NDC: 25000-091-77

Omeprazole Delayed-Release Tablets 20 mg 

14's count (2 x 7's blister) Carton





Ask A Doctor Before Use If

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





Stop Use and Ask 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





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 (1-800-222-1222).

Ask A Doctor Or Pharmacist Before Use If

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(s) (USE(S))

Uses

• 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 (PURPOSE)

Purpose 

Acid reducer





Storage (STORAGE)

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


Warnings (WARNINGS)

Warnings

Allergy alert: 

  • Do not use if you are allergic to Omeprazole
  • Omeprazole may cause severe skin reactions. Symptoms include:
    • skin reddening
    • blisters
    • rash
    If an allergic reaction occurs, stop use and seek medical attention right away.


Directions (DIRECTIONS)

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 1 tablet a day
  • do not use for 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.
Do Not Use (DO NOT USE)

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.





Active Ingredient(s) (ACTIVE INGREDIENT(S))

Active ingredient (in each tablet)                                         

Omeprazole, USP 20 mg 

(equivalent to 20.6 mg omeprazole magnesium)



Inactive Ingredients (INACTIVE INGREDIENTS)

Inactive ingredients 

colloidal silicone dioxide, crospovidone, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol 400, polyethylene glycol 6000, polysorbate 80, red iron oxide, simethicone, sodium stearyl fumarate, starch, sucrose, talc, titanium dioxide, triethyl citrate





Questions Or Comments (QUESTIONS OR COMMENTS)

Questions or comments? Call 1-877-376-4271 (weekdays 9 AM to 5 PM)



Tips for Managing Heartburn 


• Do not lie flat or bend over after eating. 

• Do not wear tight-fitting clothing around the stomach.

• Do not eat before bedtime. 

• Raise the head of your bed. 

• Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine,     alcohol and certain fruits and vegetables.      

• Eat slowly and do not eat big meals.

• If overweight, lose weight. 

• Quit smoking. 



Manufactured for:

Time-Cap Labs, Inc. 

7 Michael Avenue, 

Farmingdale, 

NY 11735, USA



Manufactured by: 

Marksans Pharma Ltd.

Plot No. L-82, L-83

Verna Indl. Estate

Verna, Goa-403722, India  





Pregnancy/breastfeeding (PREGNANCY/BREASTFEEDING)

If pregnant or breast-feeding, ask a health professional before use.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC: 25000-091-76

Omeprazole Delayed-Release Tablets 20 mg 

14's count Carton 







NDC: 25000-091-76

Omeprazole Delayed-Release Tablets 20 mg 

14's count Label 







NDC: 25000-091-77

Omeprazole Delayed-Release Tablets 20 mg 

14's count (2 x 7's blister) Carton





Ask A Doctor Before Use If (ASK A DOCTOR BEFORE USE IF)

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





Stop Use and Ask Doctor If (STOP USE AND ASK 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





Keep Out of Reach of Children (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 (1-800-222-1222).

Ask A Doctor Or Pharmacist Before Use If (ASK A DOCTOR OR PHARMACIST BEFORE USE IF)

Ask a doctor or pharmacist before use if you are taking a prescription drug. 

Acid reducers may interact with certain prescription drugs.






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