ACID REDUCER- esomeprazole magnesium capsule, delayed release 
P & L Development, LLC

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Esomeprazole Magnesium Delayed-Release Capsules 20 mg - Actavis

Drug Facts

Active ingredient (in each capsule)

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

Purpose

Acid reducer

Uses

Warnings

Allergy alert: Do not use if you are allergic to esomeprazole

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 capsule with a glass of water before eating in the morning
            •   take every day for 14 days 
            •   do not take more than 1 capsule a day 
            •   swallow whole. Do not crush or chew capsules.
            •   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 the active ingredient in Nexium® 24R†

see new warning information

24-hour

esomeprazole magnesium

delayed-release capsules

USP, 20 mg*

acid reducer

treats frequent heartburn

may take 1 to 4 days for full effect

†This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Nexium® 24HR.

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

KEEP CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by:

PL Developments

200 Hicks Street

Westbury, NY 11590

Package label

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

READYinCASE Acid Reducer

ACID REDUCER 
esomeprazole magnesium capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-056
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
ColorWHITEScoreno score
ShapeCAPSULESize14mm
FlavorImprint Code EL
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59726-056-141 in 1 CARTON12/31/2020
114 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21208812/31/2020
Labeler - P & L Development, LLC (800014821)

Revised: 1/2021
Document Id: 6556923c-1651-46fa-b815-47642e55cbb6
Set id: 08f09939-10d1-4380-81bb-826856444674
Version: 1
Effective Time: 20210114
 
P & L Development, LLC