FDA Label for Prilosec Otc
View Indications, Usage & Precautions
Prilosec Otc Product Label
The following document was submitted to the FDA by the labeler of this product Physicians Total Care, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Dist. by Procter & Gamble, Cincinnati, OH 45202
Product of Sweden
Relabeling "Additional Bar Code Label" by:
Physicians Total Care, Inc.
Tulsa, OK 74146
Active Ingredient (In Each Tablet)
Omeprazole magnesium delayed-release tablet 20.6 mg (equivalent to 20 mg omeprazole).
Purpose
Acid reducer
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
Allergy Alert
Do not use if you are allergic to omeprazole
Otc - Do Not Use
Do not use 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.
Otc - Ask 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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are 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)
Otc - Stop Use
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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 or crush tablets.
- 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
- 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 Ingredients
glyceryl monostearate, hydroxypropyl cellulose, hypromellose, iron oxide, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, paraffin, polyethylene glycol 6000, polysorbate 80, polyvinylpyrrolidone, sodium stearyl fumarate, starch, sucrose, talc, titanium dioxide, triethyl citrate
Questions?
1-800-289-9181
Principal Display Panel
NDC 54868-5309-0
Prilosec
OTC®
omeprazole magnesium delayed-
release tablets 20.6 mg / acid reducer
42 TABLETS
Treats FREQUENT Heartburn!
Occurring 2 Or More Days A Week
* Please review the disclaimer below.