Zegerid Otc

Zegerid Otc
SPL v6
SPL
SPL Set ID 5ad1ca2b-3119-b8c2-e053-2a91aa0a2f77
Route
ORAL
Published
Effective Date 2018-05-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Omeprazole (20 mg) Sodium Cation (1100 mg)
Inactive Ingredients
Monostearyl Fumarate Fd&c Red No. 40 Fd&c Blue No. 1 Polysorbate 80 Sodium Lauryl Sulfate Fd&c Blue No. 2 Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: ZEG Shape: oval Color: white Size: 23 mm Score: 1
Marketing Status
ANDA Active Since 2017-10-01

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

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

Indications and 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.

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

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

Section 50568-5

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.

Section 50569-3

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

Section 50570-1

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.

Section 51727-6

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

Section 53414-9

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

Section 55105-1

Purpose

Acid reducer

Allows absorption of this omeprazole product

Section 55106-9

Active ingredients (in each capsule)

Omeprazole 20 mg

Sodium Bicarbonate 1100 mg

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.

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

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

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


Structured Label Content

Indications and Usage (34067-9)

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 and Precautions (34071-1)

Warnings

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50568-5 (50568-5)

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.

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

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.

Section 51727-6 (51727-6)

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

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Acid reducer

Allows absorption of this omeprazole product

Section 55106-9 (55106-9)

Active ingredients (in each capsule)

Omeprazole 20 mg

Sodium Bicarbonate 1100 mg

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.

42 Count Carton (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

Other Information (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

Questions Or Comments (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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)