Omeprazole Delayed-release Tablets, 20 mg

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SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient(in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Omeprazole USP 20 mg

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

SPL UNCLASSIFIED SECTION

• 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

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 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

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 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 tablet with a glass of water before eating in the morning
  • take every day 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

STORAGE AND HANDLING 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

anhydrous lactose, hypromellose, hypromellose acetate succinate, iron oxide red, iron oxide yellow, lactose monohydrate, methyl cellulose, monoethanolamine, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, talc, triethyl citrate and titanium dioxide.

The imprinting ink contains ammonium hydroxide, black iron oxide, n-butyl alcohol, propylene glycol and shellac.

Questions or Comments?

OTC - QUESTIONS SECTION

Call 833-358-6431 M - F, 9AM - 7PM EST

SPL UNCLASSIFIED SECTION

Distributed by: McKesson Corp., via Strategic
Sourcing Services LLC. Memphis, TN 38141

PRINCIPAL DISPLAY PANEL - 20 mg Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70677-1098-1
*COMPARE TO PRILOSEC OTC^®

Foster & Thrive™

Omeprazole
Delayed-Release Tablets
20 mg / ACID REDUCER

SWALLOW- DO NOT CHEW

24 HR
Treats FREQUENT Heartburn!

One 14-day course of treatment
May take 1 to 4 days for full effect

SEE NEW WARNING INFORMATION

ACTUAL SIZE

14 TABLETS

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Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

• Omeprazole
• ANHYDROUS LACTOSE
• HYPROMELLOSE, UNSPECIFIED
• HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MM2/S)
• FERRIC OXIDE RED
• FERRIC OXIDE YELLOW
• LACTOSE MONOHYDRATE
• MONOETHANOLAMINE
• METHYLCELLULOSE (1500 MPA.S)
• PROPYLENE GLYCOL
• SODIUM STARCH GLYCOLATE TYPE A POTATO
• SODIUM STEARATE
• SODIUM STEARYL FUMARATE
• SODIUM LAURYL SULFATE
• TRIETHYL CITRATE
• TALC
• TITANIUM DIOXIDE
• AMMONIA
• FERROSOFERRIC OXIDE
• BUTYL ALCOHOL
• SHELLAC

NDC Codes#

Ingredients#

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DailyMed ingredient rows page 1 of 1 · 21 matching rows.

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Product history page 1 of 2 · 43 observed states.

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