ZEGERID OTC- omeprazole and sodium bicarbonate capsule, gelatin coated

Zegerid OTC by

Drug Labeling and Warnings

Zegerid OTC by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each capsule)

Omeprazole 20 mg

Sodium Bicarbonate 1100 mg

PURPOSE

Purpose

Acid reducer

Allows absorption of this omeprazole product

INDICATIONS & USAGE

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

Warnings

Allergy alert: Do not use if you are allergic to omeprazole

DO NOT USE

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 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 DOCTOR/PHARMACIST

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

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-1222).

Directions

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

Other information

● each tablet contains: sodium 303 mg

● read the directions, warnings and accompanying label

information before use

● store at 20°-25°C (68°-77°F)

● tamper-evident: do not use if the blue band around the

capsule is missing or broken. Do not use if foil inner seal

imprinted with “Sealed for your protection” is missing, open or

broken.

● keep product out of high heat and humidity

● protect product from moisture

INACTIVE INGREDIENT

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

Questions or comments?

Call 1-888-4-ZEG-OTC (1-888-493-4682) between 9:00 AM and 5:00 PM Eastern Standard Time, Monday through Friday

42 count carton

Treats Frequent Heartburn

Zegerid OTC ®

Omeprazole 20 mg/Acid Reducer

Sodium Bicarbonate 1100 mg/
Allows Absorption of this Omeprazole Product

42 CAPSULES

Three 14-Day Courses of Treatment

INGREDIENTS AND APPEARANCE

ZEGERID OTC 
omeprazole and sodium bicarbonate capsule, gelatin coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-7276
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)	SODIUM BICARBONATE	1100 mg

Inactive Ingredients
Ingredient Name	Strength
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-7276-1	1 in 1 CARTON	10/01/2017
1		14 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 11523-7276-2	1 in 1 CARTON	10/01/2017
2		42 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	10/01/2017

Labeler - Bayer HealthCare LLC. (112117283)