ESOMEPRAZOLE MAGNESIUM - esomeprazole magnesium capsule, delayed release 
Guardian Drug Company

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Esomeprazole Magnesium Delayed Release Capsules 

ACTIVE INGREDIENT(in each capsule)

*Esomeprazole 20 mg

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

PURPOSE

Acid reducer

USE(S)

WARNINGS

Allergy alert:

·         Do not use if you are allergic to esomeprazole.

·         Esomeprazole 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

These may be signs of a serious condition. See your doctor.

ASK A DOCTOR BEFORE USE IF YOU HAVE

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE

STOP USE AND ASK DOCTOR IF

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.

DIRECTIONS

      14-Day Course of Treatment

        Repeated 14-Day Courses (if needed)

OTHER INFORMATION

INACTIVE INGREDIENT SECTION

FD&C blue 1, FD&C red 3, FD&C red 40, ferroso  ferric oxide, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, mono and di-glycerides, polysorbate 80, potassium hydroxide, shellac, sodium lauryl sulfate, sugar spheres (contains corn starch, sucrose), talc, titanium dioxide, triethyl citrate

QUESTIONS OR COMMENTS?

Call 1-800-883-3540 (Monday - Friday 8 am - 4 pm)

OTHER SAFETY INFORMATION

Tips of Managing Heartburn


Do not use if seal under bottle cap imprinted with “SEALED FOR YOUR PROTECTION” or blue band around the center of each capsule is broken or missing.

KEEP CARTON FOR COMPLETE WARNINGS AND IMPORTANT INFORMATION.  

PRINCIPAL DISPLAY PANEL

NDC 53041-666-07

See new warning information

Esomeprazole Magnesium

Delayed-Release Capsules USP, 20 mg*

Acid Reducer

 

Treats Frequent Heartburn

24 HR Capsules

May take 1 to 4 days for full effect

14 CAPSULES - One 14-day course of treatment


   

666-GDC-14
666-GDC-14
ESOMEPRAZOLE MAGNESIUM 
esomeprazole magnesium capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53041-666
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE20 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN (UNII: 2G86QN327L)  
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
GLYCERYL MONO AND DICAPRYLOCAPRATE (UNII: U72Q2I8C85)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
SHELLAC (UNII: 46N107B71O)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorWHITE (opaque body) , BLUE (opaque cap) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint Code G666
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53041-666-071 in 1 CARTON03/24/2023
114 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21614903/24/2023
Labeler - Guardian Drug Company (119210276)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276MANUFACTURE(53041-666)

Revised: 3/2023
Document Id: d599747a-3eb5-4ea6-a63c-024393fc8fa7
Set id: 8d6c552c-16d9-4e0e-ba1a-04dce8052f95
Version: 4
Effective Time: 20230324
 
Guardian Drug Company