ESOMEPRAZOLE- esomeprazole tablet, orally disintegrating, delayed release 
Dexcel Pharma Technologies Ltd

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Esomeprazole Delayed Release Orally Disintegrating Tablets, 20 mg

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 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:

  • 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 (1-800-222-1222).

Directions

14-Day Course of Treatment

  • take 1 tablet before eating in the morning
  • do not crush or chew tablets
  • place the tablet on tongue; tablet disintegrates, with or without water. The tablets can also be swallowed whole with water.
  • take every day for 14 days
  • do not take more than 1 tablet a day
  • do not use for more than 14 days unless directed by your doctor
  • do not take this medicine with alcohol

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
  • 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

acetone, alcohol, amino methacrylate copolymer, ascorbic acid, benzyl alcohol, cetyl alcohol, colloidal silicon dioxide, crospovidone, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, flavor, hypromellose, hypromellose phthalate, isopropyl alcohol, mannitol, microcrystalline cellulose, modified starch, polysorbate 80, pregelatinized starch, silicon dioxide, sodium stearate, sodium stearyl fumarate, sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triacetin, triethyl citrate

Questions or comments? 1-800-XXX-XXXX:

Weekdays XXX AM to XXX PM EST

Tips for Managing Heartburn

NDC 64239-112-02

MELTechTM

Melts in Your Mouth

Compare to the active ingredient in Nexium® 24HR*

Treats Frequent Heartburn! 24HR

Esomeprazole

Delayed Release

Orally Disintegrating Tablets 20 mg

Acid Reducer

Melts in your mouth

Dissolves without water

14 TABLETS

One 14-day course of treatment

May take 1 to 4 days for full effect

Wildberry Flavor

Actual size

image description

NDC 64239-112-03

MELTechTM

Melts in Your Mouth

Compare to the active ingredient in Nexium® 24HR*

Treats Frequent Heartburn! 24HR

Esomeprazole

Delayed Release

Orally Disintegrating Tablets 20 mg

Acid Reducer

Melts in your mouth

Dissolves without water

28 TABLETS

Two 14-day courses of treatment

May take 1 to 4 days for full effect

Wildberry Flavor

Actual size

image description

NDC 64239-112-04

MELTechTM

Melts in Your Mouth

Compare to the active ingredient in Nexium® 24HR*

Treats Frequent Heartburn! 24HR

Esomeprazole

Delayed Release

Orally Disintegrating Tablets 20 mg

Acid Reducer

Melts in your mouth

Dissolves without water

42 TABLETS

Three 14-day courses of treatment

May take 1 to 4 days for full effect

Wildberry Flavor

Actual size

image description

NDC 64239-112-05

MELTechTM

Melts in Your Mouth 

FREE SAMPLE

Compare to the active ingredient in Nexium® 24HR*

Treats Frequent Heartburn! 24HR

Esomeprazole

Delayed Release

Orally Disintegrating Tablets 20 mg

Acid Reducer

Melts in your mouth

Dissolves without water

2 TABLETS

First 2 doses of a 14-day course of treatment

May take 1 to 4 days for full effect

Wildberry Flavor

Actual size

image description

NDC 64239-112-07

MELTechTM

Melts in Your Mouth 

Compare to the active ingredient in Nexium® 24HR*

Treats Frequent Heartburn! 24HR

Esomeprazole

Delayed Release

Orally Disintegrating Tablets 20 mg

Acid Reducer

Melts in your mouth

Dissolves without water

14 TABLETS

One 14-day course of treatment

May take 1 to 4 days for full effect

Wildberry Flavor

Actual size

image description

NDC 64239-112-08

MELTechTM

Melts in Your Mouth 

Compare to the active ingredient in Nexium® 24HR*

Treats Frequent Heartburn! 24HR

Esomeprazole

Delayed Release

Orally Disintegrating Tablets 20 mg

Acid Reducer

Melts in your mouth

Dissolves without water

28 TABLETS

Two 14-day courses of treatment

May take 1 to 4 days for full effect

Wildberry Flavor

Actual size

image description

NDC 64239-112-09

MELTechTM

Melts in Your Mouth 

Compare to the active ingredient in Nexium® 24HR*

Treats Frequent Heartburn! 24HR

Esomeprazole

Delayed Release

Orally Disintegrating Tablets 20 mg

Acid Reducer

Melts in your mouth

Dissolves without water

42 TABLETS

Three 14-day courses of treatment

May take 1 to 4 days for full effect

Wildberry Flavor

Actual size

image description

NDC 64239-112-10

MELTechTM

Melts in Your Mouth 

FREE SAMPLE

Compare to the active ingredient in Nexium® 24HR*

Treats Frequent Heartburn! 24HR

Esomeprazole

Delayed Release

Orally Disintegrating Tablets 20 mg

Acid Reducer

Melts in your mouth

Dissolves without water

2 TABLETS

First 2 doses of a 14-day course of treatment

May take 1 to 4 days for full effect

Wildberry Flavor

Actual size

image description

ESOMEPRAZOLE 
esomeprazole tablet, orally disintegrating, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64239-112
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Esomeprazole (UNII: N3PA6559FT) (ESOMEPRAZOLE - UNII:N3PA6559FT) Esomeprazole20 mg
Inactive Ingredients
Ingredient NameStrength
ACETONE (UNII: 1364PS73AF)  
ALCOHOL (UNII: 3K9958V90M)  
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CROSPOVIDONE (UNII: 2S7830E561)  
FD&C BLUE NO. 1--ALUMINUM LAKE (UNII: J9EQA3S2JM)  
FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)  
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST) (UNII: 8LDD2V82F5)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
MANNITOL (UNII: 3OWL53L36A)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STEARATE (UNII: QU7E2XA9TG)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
SORBITOL (UNII: 506T60A25R)  
STARCH, CORN (UNII: O8232NY3SJ)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorblueScoreno score
ShapeROUNDSize11mm
FlavorRASPBERRY (Wildberry) Imprint Code 20
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64239-112-072 in 1 CARTON04/12/2024
17 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:64239-112-082 in 1 CARTON04/12/2024
22 in 1 CARTON
27 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:64239-112-093 in 1 CARTON04/12/2024
32 in 1 CARTON
37 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:64239-112-101 in 1 CARTON04/12/2024
42 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:64239-112-022 in 1 CARTON04/12/2024
57 in 1 BLISTER PACK; Type 0: Not a Combination Product
6NDC:64239-112-032 in 1 CARTON04/12/2024
62 in 1 CARTON
67 in 1 BLISTER PACK; Type 0: Not a Combination Product
7NDC:64239-112-043 in 1 CARTON04/12/2024
72 in 1 CARTON
77 in 1 BLISTER PACK; Type 0: Not a Combination Product
8NDC:64239-112-051 in 1 CARTON04/12/2024
82 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA21427804/12/2024
Labeler - Dexcel Pharma Technologies Ltd (533597626)
Establishment
NameAddressID/FEIBusiness Operations
Dexcel Pharma Technologies Ltd533597626manufacture(64239-112)

Revised: 4/2022
Document Id: e0e8585e-8120-42ca-a609-bf7dab815ccc
Set id: 3922a971-b371-4159-8c34-369798809965
Version: 2
Effective Time: 20220414
 
Dexcel Pharma Technologies Ltd