Omeprazole Delayed-Release Tablets 20 mg (Wildberry Mint Coated Tablets)

Manufacturer
MARKSANS PHARMA LIMITED
Effective date
2026-08-05
Label type
Human OTC Drug Label
Version
2
Source
daily-update
Hydrated at
2026-08-08 02:01:56

Label at a glance#

ProductOmeprazole 20 mg
Active ingredientOMEPRAZOLE MAGNESIUM
Label structure15 sections

Dosage and administration

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      o swallow 1 tablet with a glass of water before eating in the morning      o take every day for 14 days      o do not take more than 1 tablet a day  ...

Storage and handling

Other information • read the directions and warnings before use • keep the carton. It contains important information. • store at 20 - 25℃ (68-77℉) and protect from moisture

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(S)

OTC - ACTIVE INGREDIENT SECTION

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



PURPOSE

OTC - PURPOSE SECTION

Purpose 

Acid reducer



USE(S)

INDICATIONS & USAGE SECTION

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

WARNINGS

WARNINGS SECTION

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

DO NOT USE

OTC - DO NOT USE SECTION

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.


ASK A DOCTOR BEFORE USE IF

OTC - ASK DOCTOR SECTION

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

ASK A DOCTOR OR PHARMACIST BEFORE USE IF

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking a prescription drug. 
Acid reducers may interact with certain prescription drugs.

STOP USE AND ASK DOCTOR IF

OTC - STOP USE SECTION

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

PREGNANCY/BREASTFEEDING

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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. 

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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
     o swallow 1 tablet with a glass of water before eating in the morning
     o take every day for 14 days
     o do not take more than 1 tablet a day
     o do not use for more than 14 days unless directed by your doctor
     o swallow whole. Do not chew, crush, or suck tablets.

  Repeated 14-Day Courses (if needed)
     o you may repeat a 14-day course every 4 months
     o 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.



STORAGE

STORAGE AND HANDLING SECTION

Other information
• read the directions and warnings before use
• keep the carton. It contains important information.
• store at 20 - 25℃ (68-77℉) and protect from moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients colloidal silicon dioxide, crospovidone, ethyl menthane carboxamide, FD and C blue no. 2 Al. lake, FD and C red no. 40 Al. lake, flavor, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, menthol, methacrylic acid and ethyl acrylate copolymer, mica, microcrystalline cellulose, polyethylene glycol 6000, polysorbate 80, propylene glycol, saccharin sodium, simethicone, sodium stearyl fumarate, starch, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

Questions or comments?

OTC - QUESTIONS SECTION

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  

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 25000-094-81
Omeprazole Delayed-Release Tablets 20 mg (Wildberry Mint Coated Tablets)
14's count (1 x 14's blister) Carton


omeprazole-wbm-14s-blister-carton-omeprazole-wbm-14s-blister-carton-


NDC: 25000-094-76
Omeprazole Delayed-Release Tablets 20 mg (Wildberry Mint Coated Tablets)
14's count Bottle Carton


omeprazole-wbm-14s-bottle-carton-
omeprazole-wbm-14s-bottle-carton-


NDC: 25000-094-76
Omeprazole Delayed-Release Tablets 20 mg (Wildberry Mint Coated Tablets)
14's count Bottle Label


omeprazole-wbm-14s-bottle-labelomeprazole-wbm-14s-bottle-label


Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130325000094768GTIN-13: 0325000094768
EAN-13: 0325000094768
GTIN-12: 325000094768
UPC-A: 325000094768
GTIN storage (14 digits): 00325000094768
omeprazole-wbm-14s-bottle-carton-.jpg
BarcodeEAN-130325000094812GTIN-13: 0325000094812
EAN-13: 0325000094812
GTIN-12: 325000094812
UPC-A: 325000094812
GTIN storage (14 digits): 00325000094812
omeprazole-wbm-14s-blister-carton-.jpg

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
25000-09425000-094-76, 25000-094-81

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 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
A218829-001OMEPRAZOLE MAGNESIUMOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2025-08-07

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A218829-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2025-08-0784e616aacf4f…
2026-08-18 06:07:402026-07A218829-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2025-08-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218829-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2025-08-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218829-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2025-08-0731067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218829-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2025-08-07a50c72e98297…

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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Omeprazole 20 mgOMEPRAZOLE 20 MGMARKSANS PHARMA LIMITED5baf6e08-8a5a-4ec0-af6d-eb73c6487e0c2026-08-05WarningsExact identifier
ndc (package): 25000-094-76
ndc (package): 25000-094-81
ndc (product): 25000-094
ndc11 (package): 25000009481
ndc11 (package): 25000009476
spl id: a18acd7b-add6-4935-a0dd-7b2a27d817ab
spl set id: 5baf6e08-8a5a-4ec0-af6d-eb73c6487e0c

Reported adverse events (FAERS/openFDA)#

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