Omeprazole Magnesium

Manufacturer
Dr. Reddy's Laboratories Inc.
Effective date
2025-07-22
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:08:23

Label at a glance#

ProductOmeprazole Magnesium
Active ingredientOMEPRAZOLE MAGNESIUM
Label structure12 sections

Dosage and administration

• 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 fo...

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Acid reducer

Use

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

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:

OTC - DO NOT USE SECTION

  • 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:

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking a prescription drug.

Acid reducers may interact with certain prescription drugs.

Stop use and ask doctor if:

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away(1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

SPL UNCLASSIFIED SECTION

• 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

black iron oxide, dibasic calcium phosphate, gelatin, glyceryl monostearate, hypromellose 3 cps, magnesium oxide, magnesium stearate, methacrylic acid copolymer dispersion, methacrylic acid copolymer Type B, microcrystalline cellulose, polysorbate 80, potassium hydroxide, propylene glycol, red iron oxide, shellac, silicon dioxide, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate

Questions

OTC - QUESTIONS SECTION

call 1-888-375-3784

Tips for Managing Heartburn

SPL UNCLASSIFIED SECTION

  • 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

Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle LabelBottle Label

Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN5
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD5
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OMEPRAZOLE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-397-27EA - Each55111-397cb783e2e-a92f-4544-908b-095fd6075f3f12015-09-10
55111-397-28EA - Each55111-3973a546396-9702-499f-8c97-c73cf8ec977a12012-07-24
55111-397-33EA - Each55111-39758ac9e87-c988-410b-b086-0aa500956a4912015-09-10
55111-397-42EA - Each55111-397fbe87769-c688-436e-bf0c-6659b849179b12012-07-24
55111-397-52EA - Each55111-39703066f2b-a765-4b49-a5d7-503ff8fffe0712013-03-03
55111-397-74EA - Each55111-397518a761d-8d23-42b2-9c1d-fa2a0f56621112012-07-24

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43598-81343598-813-14, 43598-813-33
55111-397

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078878-001OMEPRAZOLE MAGNESIUMOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-0584e616aacf4f…
2026-08-18 06:07:402026-07A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-0587673890dc5c…
2021-03-12 10:30 UTC2021-03A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-053f01610625f2…
2019-09-15 20:21 UTC2019-09A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05b00525d2431f…
2019-07-19 19:46 UTC2019-07A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-053f0d92c62455…
2023-05-13 08:27 UTC2023-05A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05053a50430f4f…
2023-01-26 05:58 UTC2023-01A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05f41ea6bd6efb…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMDr. Reddy's Laboratories Inc.fe0eb905-2042-aed1-a67d-a219e76f679b2025-07-22WarningsExact identifier
ndc (package): 43598-813-14
ndc (package): 43598-813-33
ndc (product): 43598-813
ndc11 (package): 43598081314
ndc11 (package): 43598081333
spl id: 4eefad5b-fb8f-d7f1-0138-90a07d45edfa
spl set id: fe0eb905-2042-aed1-a67d-a219e76f679b
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMDr. Reddy's Laboratories Limited0e8fde83-a55c-edaf-3c66-e1fc77d0bc112025-05-28WarningsExact identifier
ndc (product): 55111-397

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.