ACID REDUCER- esomeprazole magnesium tablet, delayed release 
Cardinal Health (Leader) 70000

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Esomeprazole Magnesium Delayed-Release Capsules 20 mg - Actavis

Drug Facts

Active ingredient (in each tablet)

Esomeprazole 20 mg
(*Each delayed-release tablet corresponds to 22.25 mg esomeprazole magnesium, USP (trihydrate))

Purpose

Acid reducer

Uses

Warnings

Allergy alert:

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 taking


Stop use and ask a 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 (1-800-222-1222) right away.

Directions

            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 
            •   swallow whole. Do not crush or chew tablets.
            •   do not use for more than 14 days unless directed by your doctor

            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

Other information

Inactive ingredients

black iron oxide, colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, low substituted hydroxypropyl cellulose, magnesium stearate, methacrylic acid - ethyl acrylate copolymer dispersion, microcrystalline cellulose, mono-and di-glycerides, polyethylene glycol, polysorbate 80, propylene glycol, red iron oxide, shellac glaze, sodium lauryl sulfate, sodium stearyl fumarate, sugar spheres (corn starch and sucrose), talc, titanium dioxide, triethyl citrate and yellow iron oxide

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO NEXIUM® 24 HR active ingredient†

24-hour

Esomeprazole Magnesium

Delayed-Release Tablets, 20 mg* | Acid Reducer

Treats Frequent Heartburn

May Take 1 to 4 days for Full Effect

TABLETS

One 14-Day Course of Treatment

SEE NEW WARNING INFORMATION

†This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, distributor of Nexium® 24HR.

TAMPER EVIDENT: DO NOT USE IF SEAL UNDER BOTTLE CAP IS BROKEN OR MISSING.

KEEP CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

Package label

Esomeprazole 20 mg (*Each delayed-release tablet corresponds to 22.25 mg esomeprazole magnesium, USP (trihydrate))

LEADER Acid Reducer

ACID REDUCER 
esomeprazole magnesium tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0095
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE20 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SUCROSE (UNII: C151H8M554)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
CROSPOVIDONE (UNII: 2S7830E561)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
ColorpinkScoreno score
ShapeCAPSULESize14mm
FlavorImprint Code EL
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0095-11 in 1 CARTON04/30/2021
114 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:70000-0095-23 in 1 CARTON04/30/2021
21 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21208804/30/2021
Labeler - Cardinal Health (Leader) 70000 (063997360)

Revised: 10/2023
Document Id: 1a222320-7601-4402-82d4-b6f5cb0c4d04
Set id: 24ee9374-aa31-44d4-85f8-47817ac023c1
Version: 7
Effective Time: 20231025
 
Cardinal Health (Leader) 70000