SPL v5
SPL
SPL Set ID 33990795-e994-4307-a570-9e8e8b44c473
Route
ORAL
Published
Effective Date 2026-01-29
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Omeprazole (20 mg)
Inactive Ingredients
Crospovidone (35 .mu.m) Glyceryl Monostearate Hydroxypropyl Cellulose (90000 Wamw) Hypromellose 2910 (5 Mpa.s) Magnesium Stearate Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A Microcrystalline Cellulose Polyethylene Glycol 4000 Polysorbate 80 Ferric Oxide Red Silicon Dioxide Sodium Hydroxide Sodium Stearyl Fumarate Dextrose, Unspecified Form Starch, Corn Sucrose Talc Titanium Dioxide Triethyl Citrate Ferric Oxide Yellow Hydroxypropyl Cellulose (45000 Wamw) Hypromellose 2910 (6 Mpa.s)

Identifiers & Packaging

Pill Appearance
Imprint: Z;69 Shape: rectangle Color: pink Size: 14 mm Score: 1
Marketing Status
ANDA Active Since 2020-09-15
Description

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 avoid big meals If overweight, lose weight Quit smoking

Purpose

Acid reducer

Medication Information

Purpose

Acid reducer

Description

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 avoid big meals If overweight, lose weight Quit smoking

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
Section 50568-5

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

Acid reducers may interact with certain prescription drugs.

Section 53413-1

 call 1-855-274-4122

Distributed by:

RUGBY® LABORATORIES

Indianapolis, IN 46268

(800) 616-2471

www.major-rugby.com



Made in India 

Section 53414-9

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

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.

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.
Other Information
  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • store at 20º to 25ºC (68º to 77ºF) and protect from moisture
Inactive Ingredients

crospovidone, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, polyethylene glycol, polysorbate 80, red iron oxide, silicified microcrystalline cellulose, sodium hydroxide, sodium stearyl fumarate, sugar spheres [which contains liquid glucose, starch (maize) and sucrose], talc, titanium dioxide,  triethyl citrate and yellow iron oxide.

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.

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 avoid big meals
  • If overweight, lose weight
  • Quit smoking
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.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222)  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
Package Label Principal Display Panel 20 Mg (14 Tablet Bottle)

Rugby®            NDC 0536-1322-88



                                    omeprazole

                 delayed-release tablets



see current Drug Facts

omeprazole delayed-release tablets 20 mg

acid reducer

24 hour



  • treats frequent heartburn


14 tablets       one 14-day course of treatment

                      may take 1 to 4 days for full effect





Package Label Principal Display Panel 20 Mg Container Carton Label

Rugby®                                        NDC 0536-1322-71



                        Compare to the active ingredient

                                          in Prilsec OTC®*

                                                 omeprazole

                                delayed-release tablets

see current Drug Facts

omeprazole delayed-release tablets 20 mg

acid reducer

24 hour



  • treats frequent heartburn             actual size


28 tablets       two 14-day courses of treatment

                      may take 1 to 4 days for full effect



  

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
Section 50568-5 (50568-5)

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

Acid reducers may interact with certain prescription drugs.

Section 53413-1 (53413-1)

 call 1-855-274-4122

Distributed by:

RUGBY® LABORATORIES

Indianapolis, IN 46268

(800) 616-2471

www.major-rugby.com



Made in India 

Section 53414-9 (53414-9)

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

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 allergic 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 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.
Other Information (Other information)
  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • store at 20º to 25ºC (68º to 77ºF) and protect from moisture
Inactive Ingredients (Inactive ingredients)

crospovidone, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, polyethylene glycol, polysorbate 80, red iron oxide, silicified microcrystalline cellulose, sodium hydroxide, sodium stearyl fumarate, sugar spheres [which contains liquid glucose, starch (maize) and sucrose], talc, titanium dioxide,  triethyl citrate and yellow iron oxide.

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.

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 avoid big meals
  • If overweight, lose weight
  • Quit smoking
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
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 (1-800-222-1222)  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
Package Label Principal Display Panel 20 Mg (14 Tablet Bottle) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablet Bottle))

Rugby®            NDC 0536-1322-88



                                    omeprazole

                 delayed-release tablets



see current Drug Facts

omeprazole delayed-release tablets 20 mg

acid reducer

24 hour



  • treats frequent heartburn


14 tablets       one 14-day course of treatment

                      may take 1 to 4 days for full effect





Package Label Principal Display Panel 20 Mg Container Carton Label (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg Container Carton Label)

Rugby®                                        NDC 0536-1322-71



                        Compare to the active ingredient

                                          in Prilsec OTC®*

                                                 omeprazole

                                delayed-release tablets

see current Drug Facts

omeprazole delayed-release tablets 20 mg

acid reducer

24 hour



  • treats frequent heartburn             actual size


28 tablets       two 14-day courses of treatment

                      may take 1 to 4 days for full effect



  

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:10.329463 · Updated: 2026-03-14T23:13:44.961646