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PRILOSEC OTC(omeprazole magnesium)tablet, delayed release
2015-01-21 18:48:00 来源: 作者: 【 】 浏览:350次 评论:0

Drug Facts

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

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, or 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, 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)

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

  • 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 inthe 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 inchildren 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

Dist. by Procter & Gamble, Cincinnati, OH 45202

Product of Sweden

PRINCIPAL DISPLAY PANEL - 14 Tablet Carton

NDC 37000-455-02

Prilosec
OTC
®
omeprazole magnesium delayed-
release tablets 20.6 mg / acid reducer

14 TABLETS
One 14-day course of treatment

Treats FREQUENT Heartburn!
Occurring
2 Or More Days A Week

PRINCIPAL DISPLAY PANEL - 14 Tablet Carton

PRILOSEC OTC
omeprazole magnesium tablet, delayed release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-455
Route of Administration ORAL DEA Schedule  
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
omeprazole magnesium (omeprazole) omeprazole magnesium 20.6mg
Inactive Ingredients
Ingredient Name Strength
GLYCERYL MONOSTEARATE  
HYDROXYPROPYL CELLULOSE  
HYPROMELLOSES  
FERRIC OXIDE RED  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
PARAFFIN  
POLYETHYLENE GLYCOL 6000  
POLYSORBATE 80  
SODIUM STEARYL FUMARATE  
SUCROSE  
TALC  
TITANIUM DIOXIDE  
TRIETHYL CITRATE  
Product Characteristics
Color PINK Score no score
Shape OVAL Size 15mm
Flavor   Imprint Code P
Contains  
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:37000-455-01 1 TABLET, DELAYED RELEASE ( TABLET) in 1 POUCH None
2 NDC:37000-455-02 1 BLISTER PACK ( BLISTER PACK) in 1 CARTON contains a BLISTER PACK
2   14 TABLET, DELAYED RELEASE ( TABLET) in 1 BLISTER PACK This package is contained within the CARTON(37000-455-02)
3 NDC:37000-455-03 2 CARTON ( CARTON) in 1 CARTON contains a CARTON
3   1 BLISTER PACK ( BLISTER PACK) in 1 CARTON This package is contained within the CARTON(37000-455-03) andcontains a BLISTER PACK
3   14 TABLET, DELAYED RELEASE ( TABLET) in 1 BLISTER PACK This package is contained within a CARTON and a CARTON(37000-455-03)
4 NDC:37000-455-04 3 CARTON ( CARTON) in 1 CARTON contains a CARTON
4   1 BLISTER PACK ( BLISTER PACK) in 1 CARTON This package is contained within the CARTON(37000-455-04) andcontains a BLISTER PACK
4   14 TABLET, DELAYED RELEASE ( TABLET) in 1 BLISTER PACK This package is contained within a CARTON and a CARTON(37000-455-04)
5 NDC:37000-455-05 1 TABLET, DELAYED RELEASE ( TABLET) in 1 BLISTER PACK None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021229 07/14/2003  

Labeler -Procter & Gamble Manufacturing Company (004238200)
Establishment
Name Address ID/FEI Operations
The Procter & Gamble Manufacturing Company (Swing Road)   003237963 PACK,REPACK,LABEL 
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