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Signature Care Omeprazole

Medically reviewed by Drugs.com. Last updated on July 2, 2020.

Dosage form: tablet, orally disintegrating, delayed release
Ingredients: OMEPRAZOLE 20mg
Labeler: Safeway
NDC Code: 21130-128

Better Living Brands LLC 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

Compare to Prilosec OTC®

Quality Guaranteed

MELTech

Melts In Your Mouth

24 HR

Omeprazole

DELAYED RELEASE ORALLY DISINTEGRATING TABLETS 20 mg

Acid Reducer

Melts in your mouth

Treats Frequent Heartburn!

Dissolves without water

STRAWBERRY Flavor

Actual Size

14 TABLETS

One 14-day course of treatment

May take 1 to 4 days for full effect

SIGNATURE CARE OMEPRAZOLE 
omeprazole tablet, orally disintegrating, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-128
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEPRAZOLE (OMEPRAZOLE) OMEPRAZOLE20 mg
Inactive Ingredients
Ingredient NameStrength
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER 
ASCORBIC ACID 
CETYL ALCOHOL 
SILICON DIOXIDE 
CROSPOVIDONE (15 MPA.S AT 5%) 
FERRIC OXIDE RED 
HYPROMELLOSE, UNSPECIFIED 
MANNITOL 
MICROCRYSTALLINE CELLULOSE 
PROPYLENE GLYCOL 
SODIUM STEARATE 
SODIUM STEARYL FUMARATE 
SORBITOL 
SUCRALOSE 
TALC 
TITANIUM DIOXIDE 
TRIETHYL CITRATE 
Product Characteristics
ColorRED (reddish) Scoreno score
ShapeROUNDSize9mm
FlavorSTRAWBERRYImprint Code20
Contains    
Packaging
#Item CodePackage Description
1NDC:21130-128-553 CARTON in 1 CARTON
114 BLISTER PACK in 1 CARTON
11 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK
2NDC:21130-128-7414 BLISTER PACK in 1 CARTON
21 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20940007/11/2018
Labeler - Safeway (009137209)

 
Safeway

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.