TOPCARE OMEPRAZOLE- omeprazole tablet, delayed release 
Topco Associates LLC

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Topco Associates LLC. Omeprazole Delayed Release Tablets 20 mg 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. 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 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

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?

1-888-423-0139

Principal Display Panel

TABLETS

Omeprazole DELAYED RELEASE TABLETS 20 mg

Acid Reducer

Treats Frequent Heartburn!

Occurring 2 Or More Days A Week

actual size

28 TABLETS

Two 14-day courses of treatment

Topcare Omeprazole Image 1
Topcare Omeprazole Image 2
TOPCARE OMEPRAZOLE 
omeprazole tablet, delayed release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-915
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE 20 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STEARATE (UNII: QU7E2XA9TG)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
MONOETHANOLAMINE (UNII: 5KV86114PT)  
Product Characteristics
Color BROWN Score no score
Shape OVAL Size 17mm
Flavor Imprint Code 20
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:36800-915-74 14 in 1 CARTON
1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2 NDC:36800-915-30 2 in 1 CARTON
2 14 in 1 CARTON
2 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
3 NDC:36800-915-55 3 in 1 CARTON
3 14 in 1 CARTON
3 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
4 NDC:36800-915-03 3 in 1 CARTON
4 14 in 1 BOTTLE; Type 0: Not a Combination Product
5 NDC:36800-915-01 1 in 1 CARTON
5 14 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022032 02/29/2008
Labeler - Topco Associates LLC (006935977)

Revised: 7/2015
Document Id: cc2f7c6c-8629-4eff-94aa-b798b319e47a
Set id: 4d98665d-38db-4c08-8406-cc0e45f7ab7c
Version: 4
Effective Time: 20150731
 
Topco Associates LLC