Prilosec OTC OMEPRAZOLE MAGNESIUM THE PROCTER & GAMBLE MANUFACTURING COMPANY FDA Approved 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
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Route
ORAL
Applications
ANDA206582

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each tablet) Omeprazole delayed-release tablet 20 mg (equivalent to 20.6 mg omeprazole magnesium)
Inactive Ingredients
Inactive ingredients acetyl tributyl citrate colloidal silicon dioxide corn starch croscarmellose sodium dextrose FD&C blue #2 FD&C red #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
Strengths
20 mg 20.6 mg
Quantities
42 tablet 42 tablets
Treats Conditions
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
Pill Appearance
Shape: oval Color: purple Imprint: 24

Identifiers & Packaging

Container Type BOX
UPC
0030772202852
UNII
426QFE7XLK
Packaging

PRINCIPAL DISPLAY PANEL - 42 Tablet Carton NEW FORMULA SAME ACTIVE INGREDIENT. SEE CURRENT DRUG FACTS. NDC 84126-301-42 Treats FREQUENT Heartburn! 24 HR Prilosec OTC ® omeprazole delayed-release tablets 20 mg / acid reducer SWALLOW - DO NOT CHEW Three 14-day courses of treatment May take 1 to 4 days for full effect. WILDBERRY Coated Tablet 42 TABLETS Procter & Gamble Prilosec Wildberry

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - 42 Tablet Carton NEW FORMULA SAME ACTIVE INGREDIENT. SEE CURRENT DRUG FACTS. NDC 84126-301-42 Treats FREQUENT Heartburn! 24 HR Prilosec OTC ® omeprazole delayed-release tablets 20 mg / acid reducer SWALLOW - DO NOT CHEW Three 14-day courses of treatment May take 1 to 4 days for full effect. WILDBERRY Coated Tablet 42 TABLETS Procter & Gamble Prilosec Wildberry

Overview

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

Indications & Usage

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

Dosage & 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 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, crush, or suck 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.

Warnings & Precautions
Warnings 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.
Purpose

Purpose Acid reducer

Do Not Use

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.

Stop Use & Ask a Doctor

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

Keep Out of Reach of Children

Keep out of reach of children.

Storage & Handling

Other information 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

Questions

Questions? 1-800-289-9181


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