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

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Sam’s West, Inc. Omeprazole Delayed Release Orally Disintegrating Tablets 20 mg 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

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 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

take 1 tablet before eating in the morning
do not crush or chew tablets
place the tablet on tongue; tablet disintegrates, with or without water. The tablets can also be swallowed whole with water.
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
do not take this medicine with alcohol

Repeated 14-Day Course (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 before use. 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); keep product out of high heat and moisture

Inactive ingredients

amino methacrylate copolymer, ascorbic acid, cetyl alcohol, colloidal silicon dioxide, crospovidone, ferric oxide, flavor, hypromellose, hypromellose phthalate, maize maltodextrin, mannitol, microcrystalline cellulose, propylene glycol, silicon dioxide, sodium stearate, sodium stearyl fumarate, sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate

Questions or comments?

1-800-719-9260: weekdays 7:30 AM to 5:00 PM EST

Package/Label Principal Display Panel

M Member’s Mark

Melts in your mouth

Dissolves without water

MELTech Melts In Your Mouth

Compare to Prilosec OTC®

Omeprazole

Delayed release orally disintegrating tablets 20 mg • Acid reducer

STRAWBERRY FLAVOR

orally disintegrating tablets

Treats FREQUENT Heartburn!

24 HR

actual size

Three 14-day courses of treatment. May take 1 to 4 days for full effect.

42 Tablets

omeprazole-image
MEMBERS MARK OMEPRAZOLE 
omeprazole tablet, orally disintegrating, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-303
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20 mg
Inactive Ingredients
Ingredient NameStrength
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MANNITOL (UNII: 3OWL53L36A)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM STEARATE (UNII: QU7E2XA9TG)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorRED (reddish) Scoreno score
ShapeROUNDSize9mm
FlavorSTRAWBERRYImprint Code 20
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68196-303-553 in 1 CARTON05/10/2018
114 in 1 CARTON
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20940005/10/2018
Labeler - Sam's West Inc (051957769)

Revised: 1/2023
Document Id: 8ece4520-ea8a-4372-86c6-964dfcef18b2
Set id: 58256e7e-6f1d-40fb-9b58-968c682fb945
Version: 3
Effective Time: 20230123
 
Sam's West Inc