MEMBERS MARK OMEPRAZOLE- omeprazole tablet, delayed release 
Sam's West Inc

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Sam’s West, Inc. Omeprazole 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.
omeprazole may cause severe skin reactions. Symptoms may include:
skin reddening
blisters
rash

If an allergic reaction occurs, stop use and seek medical help right away.

Do not use if you have:

trouble or pain swallowing food, vomiting with blood, or bloody or black stools
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

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.
frequent wheezing, particularly with heartburn
unexplained weight loss
nausea or vomiting
stomach pain

Ask a doctor or pharmacist before use if you are

taking a prescription drug. Acid reducers 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; 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, crush, or suck 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

benzyl alcohol, carmine, carnauba wax, FD&C blue #2/indigo carmine aluminum lake, flavor, hypromellose, hypromellose acetate succinate, lactose monohydrate, menthol, modified starch, monoethanolamine, polyethylene glycol 3350, sodium lauryl sulfate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, sucralose, talc, titanium dioxide, triacetin, triethyl citrate

Questions or comments?

1-800-809-0469

Package/Label Principal Display Panel

Member’s Mark

COMPARE TO PRILOSEC OTC®

VALUE PACK! THREE-14 TABLET BOTTLES

Omeprazole

DELAYED RELEASE TABLETS 20 mg | ACID REDUCER

Treats Frequent Heartburn! | 24 HR

WILDBERRY MINT COATED TABLET | SWALLOW – DO NOT CHEW

42 TABLETS | THREE 14-DAY COURSES OF TREATMENT.

ACTUAL SIZE | MAY TAKE 1 TO 4 DAYS FOR FULL EFFECT

401-zy-omeprazole
MEMBERS MARK OMEPRAZOLE 
omeprazole tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-700
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20 mg
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CARMINIC ACID (UNII: CID8Z8N95N)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
HYPROMELLOSE ACETATE SUCCINATE, UNSPECIFIED (UNII: A7ZHS2RJ34)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
MONOETHANOLAMINE (UNII: 5KV86114PT)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STEARATE (UNII: QU7E2XA9TG)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorPURPLEScoreno score
ShapeOVALSize12mm
FlavorBERRYImprint Code 20
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68196-700-0114 in 1 BOTTLE; Type 0: Not a Combination Product02/07/2024
2NDC:68196-700-033 in 1 CARTON02/07/2024
214 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02203202/07/2024
Labeler - Sam's West Inc (051957769)

Revised: 3/2024
Document Id: 7292128d-5bd2-4239-b53d-22ec365a835e
Set id: 907e9974-46b8-4dae-be92-518c076cb98f
Version: 2
Effective Time: 20240307
 
Sam's West Inc