Prilosec OTC Tablets (Procter & Gamble)

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Drug Facts:

ACTIVE INGREDIENTS

Omeprazole magnesium delayed-release tablet 20.6 mg

(equivalent to 20 mg omeprazole)

USES

• 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

Do not use if you have

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

Ask a doctor before use if you have

• 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

Ask a doctor or pharmacist before use if you are taking

• warfarin (blood-thinning medicine)
• prescription antifungal or anti-yeast medicines
• diazepam (anxiety medicine)
• digoxin (heart medicine)

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

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS

• 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, although 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 chew or crush the tablets
  • do not crush tablets in food
  • do not use for more than 14 days unless directed by your doctor
  
     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

OTHER INFORMATION

• read the directions, warnings and package insert before use
• keep the carton and package insert. They contain important information.
• store at 20-25°C (68-77°F)
• keep product out of high heat and humidity
• protect product from moisture

INACTIVE INGREDIENTS

Glyceryl monostearate, hydroxypropyl cellulose, hypromellose, iron oxide, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, paraffin, polyethylene glycol 6000, polysorbate 80, polyvinylpyrrolidone, sodium stearate fumarate, starch, sucrose, talc, titanium dioxide, triethyl citrate

HOW SUPPLIED

Available in: 2-count child-resistant sample pouches and 14-count, 28-count and 42-count boxes containing child-resistant blister-packs (1, 2, and 3 14 day courses of treatment, respectively). Tablets are pink with a P debossing.

Questions: 1-800-289-9181

Manufactured by Astrazeneca

Dist. by Procter & Gamble, Cincinnati OH 45202

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