Your browser does not support JavaScript! HEALTH MART OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [MCKESSON]
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RxNorm Names

HEALTH MART OMEPRAZOLE (omeprazole) tablet, delayed release
[McKesson]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL New Drug Application
Drug Label Sections

Active ingredient (in each tablet)

Omeprazole 20 mg

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
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 20mg

acid reducer

treats frequent heartburn!

occurring 2 or more days a week

ACTUAL SIZE

acid reducer

# 14-day course of treatment {Replace “#” with the number of courses of treatment in the carton}

Omeprazole Carton Image
HEALTH MART OMEPRAZOLE 
omeprazole tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:62011-0157
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 Code 20
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62011-0157-22 in 1 CARTON
11 in 1 CARTON
114 in 1 BLISTER PACK
2NDC:62011-0157-11 in 1 CARTON
214 in 1 BLISTER PACK
3NDC:62011-0157-33 in 1 CARTON
31 in 1 CARTON
314 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02203203/20/2012
Labeler - McKesson (177667227)

Revised: 2/2013
 
McKesson

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