Fulton Street Market Omeprazole

Dosage form: tablet, delayed release
Ingredients: OMEPRAZOLE 20mg
Labeler: Access Business Group LLC
NDC Code: 10056-666

Access Business Group LLC omeprazole Drug Facts

Active ingredient (in each tablet)

Omeprazole 20 mg

Purpose

Acid reducer

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, 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
you get diarrhea

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. (1-800-222-1222)

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

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.

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

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

Questions or comments?

1-800-719-9260

Principal Display Panel

omeprazole delayed release tablets 20 mg

acid reducer

treats frequent heartburn!

occurring 2 or more days a week

42 TABLETS Three 14-day courses of treatment

FULTON STREET MARKET OMEPRAZOLE 
omeprazole tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10056-666
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEPRAZOLE (OMEPRAZOLE) OMEPRAZOLE20 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
HYPROMELLOSES 
LACTOSE MONOHYDRATE 
PROPYLENE GLYCOL 
SODIUM LAURYL SULFATE 
SODIUM STEARATE 
SODIUM STEARYL FUMARATE 
TALC 
TITANIUM DIOXIDE 
TRIETHYL CITRATE 
MONOETHANOLAMINE 
Product Characteristics
ColorBROWNScoreno score
ShapeOVALSize17mm
FlavorImprint Code20
Contains    
Packaging
#Item CodePackage Description
1NDC:10056-666-553 BLISTER PACK in 1 CARTON
114 TABLET, DELAYED RELEASE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02203207/08/2009
Labeler - Access Business Group LLC (839830713)

Revised: 10/2013
 
Access Business Group LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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