NEXIUM 24HR- esomeprazole magnesium tablet 
Haleon US Holdings LLC

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Drug Facts

Active ingredient (in each tablet)

Esomeprazole 20 mg

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

Purpose

Acid reducer

Uses

Warnings

Allergy alert

  • Do not use if you are allergic to esomeprazole
  • Esomeprazole may cause severe skin reactions. Symptoms include:
  • skin reddening
  • blisters
  • rash

If an allergic reaction occurs, stop use and seek medical attention 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 right away.

Directions

Other Information

Inactive ingredients

corn starch, crospovidone, D&C red no. 27 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, mica, microcrystalline cellulose, paraffin, polyethylene glycol, polysorbate 80, sodium stearyl fumarate, sucrose, talc, titanium dioxide, triethyl citrate

Questions or comments?

call toll-free weekdays 9 AM to 5 PM EST at 1-866-226-1600

Additional Information

KEEP CARTON FOR COMPLETE WARNINGS AND IMPORTANT INFORMATION.

Do Not Use if seal under bottle cap imprinted with “SEALED for YOUR PROTECTION”

or yellow band around the center of each capsule is broken or missing.

Tips for Managing Heartburn

Distributed by: GSK Consumer Healthcare,

Warren, NJ 07059

©2022 GSK group of companies or its licensor

Made in France

For most recent product information, visit www.Nexium24HR.com

Nexium is a registered trademark of AstraZeneca AB and is used under license.

PRINCIPAL DISPLAY PANEL

NDC 0573-2451-14

See new warning information

Treats Frequent Heartburn

Nexium®
24HR

esomeprazole magnesium

delayed-release tablets
20 mg/acid reducer

Tablets

May take 1 to 4 days for full effect

14
TABLETS

One 14-day course of treatment

000078388 Front Carton

Nexium 24 Hr Tablets  14ct
NEXIUM 24HR 
esomeprazole magnesium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-2451
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)  
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
MICA (UNII: V8A1AW0880)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
PARAFFIN (UNII: I9O0E3H2ZE)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorpurpleScoreno score
ShapeOVALSize14mm
FlavorImprint Code N;20;mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-2451-141 in 1 CARTON02/06/2016
114 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0573-2451-423 in 1 BLISTER PACK02/06/2016
214 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:0573-2451-282 in 1 CARTON07/01/202108/31/2021
314 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:0573-2451-433 in 1 PACKAGE07/01/202108/31/2021
414 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20792002/06/2016
Labeler - Haleon US Holdings LLC (079944263)

Revised: 3/2024
Document Id: 14093cfd-a649-5d38-e063-6294a90a7c5f
Set id: 61f67858-ba2f-449b-8b30-c15cdaf49222
Version: 11
Effective Time: 20240319
 
Haleon US Holdings LLC