TOPCARE OMEPRAZOLE AND SODIUM BICARBONATE- omeprazole, sodium bicarbonate capsule, gelatin coated

topcare omeprazole and sodium bicarbonate by

Drug Labeling and Warnings

topcare omeprazole and sodium bicarbonate by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each capsule)

Omeprazole 20 mg

Sodium Bicarbonate 1100 mg

Purpose

Acid reducer

Allows absorption of this omeprazole product

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
• 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
• a sodium-restricted diet

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)
• any other prescription drugs. Sodium bicarbonate may interact with certain prescription drugs.

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, although some people get complete relief of symptoms within 24 hours

14-Day Course of Treatment

• swallow 1 capsule with a glass of water at least 1 hour before eating in the morning
• take every day for 14 days
• do not take more than 1 capsule a day
• do not chew or crush the capsule
• do not open capsule and sprinkle on food
• do not use for more than 14 days unless directed by your doctor

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

• each capsule contains: sodium 303 mg
• read the directions, warnings and accompanying label information before use
• store at 20-25oC (68-77oF)
• tamper-evident: do not use if the band around the capsule is missing or broken. Do not use if printed seal under cap is broken or missing.
• keep product out of high heat and humidity
• protect product from moisture

Inactive ingredients

FD&C blue no. 1, FD&C blue no. 2 aluminum lake, FD&C red no. 40, gelatin, polysorbate 80, sodium lauryl sulfate, sodium starch glycolate, sodium stearyl fumarate, titanium dioxide

Questions or comments?

1-888-423-0139

Package/Label Principal Display Panel

TREATS FREQUENT HEARTBURN

Omeprazole and Sodium Bicarbonate

CAPSULES 20 mg / 1100 mg

Acid Reducer

Allows Absorption of this Omeprazole Product

COMPARE TO ZEGERID OTC® active ingredients

actual size

42 CAPSULES

Three 14-day courses of treatment

INGREDIENTS AND APPEARANCE

TOPCARE OMEPRAZOLE AND SODIUM BICARBONATE 
omeprazole, sodium bicarbonate capsule, gelatin coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-732
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9)	OMEPRAZOLE	20 mg
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20)	SODIUM BICARBONATE	1100 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (blue band)	Score	no score
Shape	OVAL	Size	23mm
Flavor		Imprint Code	732
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-732-03	3 in 1 CARTON	03/13/2017
1		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
ANDA	ANDA201361	03/13/2017

Labeler - Topco Associates LLC (006935977)