OMEPRAZOLE MAGNESIUM DELAYED-RELEASE TABLETS

Manufacturer
Family Dollar (FAMILY WELLNESS)
Effective date
2025-02-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:41:14

Label at a glance#

ProductOmeprazole
Active ingredientOMEPRAZOLE MAGNESIUM
Label structure16 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 tablet with a glass of water before eating in the morning take everyday for 14 days do not take more than 1 tablet a day do not use for more than 14 days unless dir...

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Omeprazole delayed-release tablet 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    Ÿ
  • 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 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

  • 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 everyday 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

SPL UNCLASSIFIED SECTION

  • read the directions and warnings before use
  • Keep the carton. It contains important information.
  • store at 20° to 25°C (68° to 77°F) and protect from moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

acetyl tributyl citrate, colloidal silicon dioxide, corn starch, croscarmellose sodium, dextrose, FD&C blue no. 2, FD&C red no.40, flavor, hydroxypropyl cellulose, hypromellose 2910, magnesium stearate, methacrylic acid copolymer type C, microcrystalline cellulose, polyethylene glycol 400, polyethylene glycol 3350, polyethylene glycol 8000, polysorbate 80, polyvinyl alcohol, propylene glycol, sucralose, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

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

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

†COMPARE TO THE ACTIVE INGREDIENT IN PRILOSEC OTC®

OMEPRAZOLE

Delayed-release tablets 20 mg

Acid reducer

TREAT FREQUENT HEARTBURN

  • One 14-day course of treatment
  • May take 1 to 4 days for full effect
  • SWALLOW-DO NOT CHEW

COATED WITH WILDBERRY FLAVOR

TABLETS

†This product is not affiliated with, manufactured by or produced by the makers or owners of Prilosec OTC®.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

DISTRIBUTED BY: MIDWOOD BRANDS LLC,

500 VOLVO PKWY, CHESAPEAKE, VA 23320

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FAMILY WELLNESS Acid Reducer Wildberry Flavor
FAMILY WELLNESS Acid Reducer Wildberry Flavor

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55319-29755319-297-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Source Document#

Source XML

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
784a78ee-9eb3-4c58-b8dc-3fd24dc4a0a738d59a6c-4220-4e90-9cf6-e2de10d82fbc2025-02-18WarningsExact identifier
spl id: 784a78ee-9eb3-4c58-b8dc-3fd24dc4a0a7
spl set id: 38d59a6c-4220-4e90-9cf6-e2de10d82fbc

Reported adverse events (FAERS/openFDA)#

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