Esomeprazole Magnesium Delayed-Release Capsules 20 mg - Actavis

Manufacturer
P & L Development, LLC
Effective date
2023-04-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:32:53

Label at a glance#

ProductEsomeprazole Magnesium
Active ingredientESOMEPRAZOLE MAGNESIUM
Label structure16 sections

Indications and 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

Dosage and administration

adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days may take 1 to 4 days for full effect             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              •   swallow whole. Do not crush or...

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Esomeprazole 20 mg
(*Each delayed-release capsule corresponds to 21.7 mg esomeprazole magnesium dihydrate)

Purpose

OTC - PURPOSE SECTION

Acid reducer

Uses

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 esomeprazole

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 taking

OTC - ASK DOCTOR/PHARMACIST SECTION

  • warfarin, clopidogrel or cilostazol (blood-thinning medicines)
  • prescription antifungal or anti-yeast medicines
  • digoxin (heart medicine)
  • diazepam (anxiety medicine)
  • tacrolimus or mycophenolate mofetil (immune system medicines)
  • prescription antiretrovirals (medicines for HIV infection)
  • methotrexate (arthritis medicine)

Stop use and ask a 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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults 18 years of age and older
  • this product is to be used once a day (every 24 hours), every day for 14 days
  • may take 1 to 4 days for full effect

            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 
            •   swallow whole. Do not crush or chew capsules.
            •   do not use for more than 14 days unless directed by your doctor

            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 before use. Heartburn in children may sometimes be caused by a serious condition.

Other information

SPL UNCLASSIFIED SECTION

  • read the directions and warnings before us
  • keep the carton. It contains important information.
  • store at 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

gelatin, hypromellose, magnesium stearate, methacrylic acid copolymer dispersion type C, mono-and di-glycerides, polysorbate 80, sodium lauryl sulfate, sugar spheres (contain sucrose, corn starch and purified water), talc, titanium dioxide, triethyl citrate.

Each capsule is imprinted with blue pharmaceutical ink which contains butyl alcohol, dehydrated alcohol, FD&C Blue No 2 aluminum lake, isopropyl alcohol, propylene glycol, shellac, strong ammonia solution and having two parallel bands which contains FD&C Blue No 2 aluminum lake, gelatin and polysorbate 80

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

**Compare to the active ingredient in Nexium® 24R

24-hour

esomeprazole magnesium

delayed-release capsules

USP, 20 mg*

acid reducer

treats frequent heartburn

may take 1 to 4 days for full effect

**This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Nexium® 24HR.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP OR BAND AROUND THE CENTER OF EACH CAPSULE IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Distributed by:

PL Developments

200 Hicks Street

Westbury, NY 11590

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

READYinCASE 24-Hour esomeprazole magnesium
READYinCASE 24-Hour esomeprazole magnesium

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59726-912ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [P & L DEVELOPMENT, LLC]2Legacy NDC20230419_777e1cf2-2cda-4c47-9fac-10f670d279ed.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59726-91259726-912-14
69238-1050

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
A209716-001ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2019-06-05

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
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2026-08-18 06:07:402026-07A209716-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2019-06-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209716-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2019-06-05011fe1cb6892…
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2025-08-23 18:47 UTC2025-08A209716-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2019-06-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209716-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2019-06-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209716-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2019-06-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209716-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2019-06-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209716-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2019-06-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209716-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2019-06-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209716-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2019-06-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209716-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2019-06-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209716-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2019-06-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209716-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2019-06-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209716-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2019-06-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209716-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2019-06-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209716-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2019-06-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209716-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2019-06-055d02ea3f76ae…
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2019-09-15 20:21 UTC2019-09A209716-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2019-06-05b00525d2431f…
2019-07-19 19:46 UTC2019-07A209716-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2019-06-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209716-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2019-06-056a51e52b5d6a…
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2023-12-20 04:57 UTC2023-12A209716-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2019-06-05ea1830bbd6c7…
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2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209716-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2019-06-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209716-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2019-06-053f0d92c62455…
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2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209716-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2019-06-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209716-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2019-06-05f41ea6bd6efb…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
27cf4062-a8b8-4a2a-a90c-06b505cd8733777e1cf2-2cda-4c47-9fac-10f670d279ed2023-04-18WarningsExact identifier
spl id: 27cf4062-a8b8-4a2a-a90c-06b505cd8733
spl set id: 777e1cf2-2cda-4c47-9fac-10f670d279ed

Reported adverse events (FAERS/openFDA)#

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