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TopCare Omeprazole delayed release

Dosage form: tablet, delayed release
Ingredients: OMEPRAZOLE 20mg
Labeler: Topco Associates LLC
NDC Code: 36800-121

Topco Associates LLC. Omeprazole Delayed Release Tablets Drug Facts

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
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

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.
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 or mycophenolate mofetil (immune system medicines)
prescription antiretrovirals (medicines for HIV infection)
methotrexate (arthritis 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
you get diarrhea
you develop a rash or joint pain

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, crush, or suck 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

benzyl alcohol, carmine, carnauba wax, FD&C blue #2/indigo carmine aluminum lake, flavor, hypromellose, hypromellose acetate succinate, lactose monohydrate, menthol, modified starch, monoethanolamine, polyethylene glycol 3350, sodium lauryl sulfate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, sucralose, talc, titanium dioxide, triacetin, triethyl citrate

Questions or comments?

1-888-423-0139

Package/Label Principal Display Panel

1 Bottle Inside

COMPARE TO PRILOSEC OTC®

OUR PHARMACISTS RECOMMEND

Omeprazole

DELAYED RELEASE TABLETS 20 mg ACID REDUCER

Treats Frequent Heartburn!

Occurring 2 or More Days a Week

COATED WITH WILDBERRY MINT FLAVOR

SWALLOW – DO NOT CHEW

14 TABLETS

ONE 14-DAY COURSE OF TREATMENT

actual size

TOPCARE OMEPRAZOLE DELAYED RELEASE 
omeprazole tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-121
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEPRAZOLE (OMEPRAZOLE) OMEPRAZOLE20 mg
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
CARNAUBA WAX 
FD&C BLUE NO. 2 
HYPROMELLOSES 
LACTOSE MONOHYDRATE 
MENTHOL 
MONOETHANOLAMINE 
POLYETHYLENE GLYCOL 3350 
SODIUM LAURYL SULFATE 
SODIUM STEARATE 
SODIUM STEARYL FUMARATE 
SUCRALOSE 
TALC 
TITANIUM DIOXIDE 
TRIACETIN 
TRIETHYL CITRATE 
Product Characteristics
ColorPURPLEScoreno score
ShapeOVALSize12mm
FlavorBERRYImprint Code20
Contains    
Packaging
#Item CodePackage Description
1NDC:36800-121-011 BOTTLE in 1 CARTON
114 TABLET, DELAYED RELEASE in 1 BOTTLE
2NDC:36800-121-033 BOTTLE in 1 CARTON
214 TABLET, DELAYED RELEASE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02203202/02/2016
Labeler - Topco Associates LLC (006935977)

 
Topco Associates LLC

Medically reviewed on May 30, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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