FDA.reportPublic FDA data

Acid Reducer

Manufacturer
LEADER/ Cardinal Health 110, Inc.
Effective date
2025-07-23
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-06-01 01:08:42

Label at a glance#

ProductAcid Reducer
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 for more than 14 days unle...

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 capsule 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 sulphate, 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

Acid Reducer Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER™

NDC 70000-0232-1

Acid Reducer
Omeprazole
Delayed-release Capsules, 20 mg*

Treats Frequent Heartburn

14 DELAYED-RELEASE CAPSULES
One 14-Day Course of Treamtent

May take 1 to 4 days for full effect

COMPARE TO
PRILOSEC OTC®
active ingredient**

100% Money
Back Guarantee

cartoncarton

Acid Reducer Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER™
NDC 70000-0232-1

Acid Reducer  
Omeprazole 
Delayed-release Capsules, 20 mg*

Treats Frequent Heartburn

May take 1 to 4 days for full effect

14 DELAYED-RELEASE CAPSULES  
One 14-Day Course of Treatment

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN12
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD12
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY12

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0232-1EA - Each70000-023232aa9784-26f0-4b50-85bb-75eeb386b72212017-12-14
70000-0232-2EA - Each70000-02322f4fb323-597a-4f69-9d73-f5056dea9ebb12017-12-14
70000-0232-3EA - Each70000-0232f834d6f0-84e3-4a34-8e2d-c6e7ce7002c512017-12-14
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 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-023270000-0232-1, 70000-0232-2, 70000-0232-3
55111-397

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
OMEPRAZOLE MAGNESIUM426QFE7XLKACTIM
FERROSOFERRIC OXIDEXM0M87F357IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
Gelatin2G86QN327LIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HYPROMELLOSE 2208 (3 MPA.S)9H4L916OBUIACT
Magnesium Oxide3A3U0GI71GIACT
MAGNESIUM STEARATE70097M6I30IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)5KY68S2577IACT
Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type ANX76LV5T8JIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
Polysorbate 806OZP39ZG8HIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
FERRIC OXIDE RED1K09F3G675IACT
SHELLAC46N107B71OIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
RAW SUGAR8M707QY5GHIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
Sodium Lauryl Sulfate368GB5141JIACT

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 44.

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05c2088c7a36db…
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…

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
Acid ReducerOMEPRAZOLE MAGNESIUMLEADER/ Cardinal Health 110, Inc.1dc00f13-d1f5-15a0-32cc-4fc041865e722025-07-23WarningsExact identifier
ndc (package): 70000-0232-1
ndc (package): 70000-0232-2
ndc (package): 70000-0232-3
ndc (product): 70000-0232
ndc11 (package): 70000023202
ndc11 (package): 70000023201
ndc11 (package): 70000023203
spl id: 7dcc8f17-f79a-325e-bb4f-181efdfc0457
spl set id: 1dc00f13-d1f5-15a0-32cc-4fc041865e72
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.