GOOD SENSE OMEPRAZOLE AND SODIUM BICARBONATE- omeprazole, sodium bicarbonate capsule, gelatin coated 
L. Perrigo Company

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Perrigo Omeprazole and Sodium Bicarbonate Drug Facts

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
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, 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 20-25 oC (68-77 oF)
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?

1-800-719-9260

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 active ingredients of Zegerid OTC®

100% SATISFACTION GUARANTEED

42 Capsules

Three 14-Day Courses of Treatment

Package Contains 3 Bottles

732-c2-92-omeprazole-and-sodium-bicarbonate-1.jpg
732-c2-92-omeprazole-and-sodium-bicarbonate-2.jpg
GOOD SENSE OMEPRAZOLE AND SODIUM BICARBONATE 
omeprazole, sodium bicarbonate capsule, gelatin coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0113-0058
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 BLUE NO. 2 (UNII: L06K8R7DQK)  
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 CAPSULE Size 23mm
Flavor Imprint Code 732
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0113-0058-03 3 in 1 CARTON 06/19/2017
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 06/19/2017
Labeler - L. Perrigo Company (006013346)

Revised: 5/2018
Document Id: 5602b990-789b-4c28-a49f-337d071fa536
Set id: bcf32242-de17-4da1-b707-4ce26262eb78
Version: 2
Effective Time: 20180523
 
L. Perrigo Company