OTC - ACTIVE INGREDIENT

Omeprazole 20 mg

OTC - PURPOSE

Acid reducer

INDICATIONS & USAGE

•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

Allergy alert: Do not use if you are allergic to omeprazole

if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.

•had heartburn over 3 months. This may be a sign of a more serious condition.•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 •frequent wheezing, particularly with heartburn •unexplained weight loss•nausea or vomiting•stomach pain

taking

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

•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

ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

DOSAGE & 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 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.

STORAGE AND HANDLING

•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 INGREDIENT

carnauba wax, ferric oxide red, ferric oxide yellow, hypromellose, hypromellose acetate succinate, lactose monohydrate, monoethanolamine, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, talc, titanium dioxide, triethyl citrate

OTC - QUESTIONS

1-800-719-9260

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: omeprazole

GENERIC: Omeprazole

DOSAGE: TABLET, DELAYED RELEASE

ADMINSTRATION: ORAL

NDC: 52125-633-04

ACTIVE INGREDIENT(S):

• OMEPRAZOLE 20mg in 1

INACTIVE INGREDIENT(S):

• CARNAUBA WAX
• SODIUM STEARYL FUMARATE
• TALC
• SODIUM STEARATE
• TITANIUM DIOXIDE
• TRIETHYL CITRATE
• MONOETHANOLAMINE
• FERRIC OXIDE RED
• FERRIC OXIDE YELLOW
• HYPROMELLOSES
• LACTOSE MONOHYDRATE
• PROPYLENE GLYCOL
• SODIUM LAURYL SULFATE

COLOR: brown

SHAPE: OVAL

SCORE: No score

SIZE: 17 mm

IMPRINT: 20

PACKAGING: 14 in 1 CARTON