ESOMEPRAZOLE MAGNESIUM- esomeprazole magnesium capsule, delayed release 
BETTER LIVING BRANDS LLC.

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Albertsons ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE 20 MG MINI

Drug Facts

Active ingredient (in each capsule)

Esomeprazole 20 mg

(Each delayed-release capsule corresponds to 22.3 mg esomeprazole magnesium trihydrate)

Purpose

Acid reducer

Uses

Warnings

Allergy alert

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 (1-800-222-1222) right away.

Directions

-adults 18 years of age and older

-this product is to be used once a day (every 24 hours), every day for 14 days

-may take 1 to 4 days for full effect

14-Day Course of Treatment

Repeated 14-Day Courses (if needed)

-children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition.

Other information

Inactive ingredients black iron oxide, corn starch, D&C red 27 aluminum lake, eudragit, FD&C blue 1, FD&C red 3, ferric oxide yellow, gelatin, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, polysorbate 80, potassium hydroxide, shellac, simethicone, sodium lauryl sulfate, sucrose, talc, titanium dioxide, triethyl citrate

Questions or comments? Call 1-877-290-4008

eso-minis-14s-labeleso-minis-42s-ifceso-minis-14s-ifc

ESOMEPRAZOLE MAGNESIUM 
esomeprazole magnesium capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-257
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE20 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
TALC (UNII: 7SEV7J4R1U)  
SHELLAC (UNII: 46N107B71O)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SUCROSE (UNII: C151H8M554)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
GELATIN (UNII: 2G86QN327L)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
Product Characteristics
Coloryellow (golden yellow opaque cap, transparent body, light violet to violet color band) Scoreno score
ShapeCAPSULESize11mm
FlavorImprint Code 112
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-257-451 in 1 CARTON04/29/2024
114 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:21130-257-413 in 1 CARTON04/29/2024
214 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21726404/29/2024
Labeler - BETTER LIVING BRANDS LLC. (009137209)
Registrant - TIME CAP LABORATORIES, INC. (037052099)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LIMITED925822975manufacture(21130-257)

Revised: 4/2024
Document Id: 16821d33-b446-b089-e063-6294a90ab73f
Set id: f2c06861-0324-93ed-e053-2995a90a5902
Version: 2
Effective Time: 20240420
 
BETTER LIVING BRANDS LLC.