ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES, 20 MG capsule, delayed release ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE 20 MG MINI capsule, delayed release

Esomeprazole Magnesium Delayed-Release Capsules, 20 mg by

Drug Labeling and Warnings

Esomeprazole Magnesium Delayed-Release Capsules, 20 mg by is a Otc medication manufactured, distributed, or labeled by MARKSANS PHARMA LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each capsule)

Esomeprazole 20 mg

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

Purpose

Acid reducer

Uses

 treats frequent heartburn (occurs 2 or more days a week)
 not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Warnings

Allergy alert:

 Do not use if you are allergic to esomeprazole
 Esomeprazole may cause severe skin reactions. Symptoms include:
o skin reddening
o blisters
o 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 (1-800-222-1222) right away.

Directions

• adults 18 years of age and older
• this product is to be used once a day (every 24 hours), every day for 14 days
• may take 1 to 4 days for full effect

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

• children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition.

Other information

 read the directions and warnings before use
 keep the carton. It contains important information.
 store at 20-25°C (68-77°F)

Inactive ingredients

Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg

Inactive ingredients black iron oxide, eudragit, FD&C Blue 1, FD&C Red 3, ferric oxide yellow, gelatin, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, polysorbate 80, potassium hydroxide, shellac, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate.

Esomeprazole Magnesium Delayed-Release Capsules 20 mg (Mini Capsules) 

Inactive ingredients black iron oxide, corn starch, D&C red 27 aluminum lake, eudragit, FD&C blue 1, FD&C red 3, ferric oxide yellow, gelatin, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, polysorbate 80, potassium hydroxide, shellac, simethicone, sodium lauryl sulfate, sucrose, talc, titanium dioxide, triethyl citrate

Questions or comments

Call 1-877-376-4271 (weekdays 9 AM to 5 PM)

Tips for Managing Heartburn
 Avoid foods or drinks that are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some acidic fruits and vegetables.
 Eat slowly and do not eat big meals.
 Do not eat late at night or just before bedtime.
 Do not lie flat or bend over soon after eating.
 Raise the head of your bed.
 Wear loose-fitting clothing around your stomach.
 If you are overweight, lose weight.
 If you smoke, quit smoking.

Manufactured for:
Time-Cap Labs, Inc.
7 Michael Avenue,
Farmingdale,
NY 11735, USA

Manufactured by:
Marksans Pharma Ltd.
Plot No. L-82, L-83
Verna Indl. Estate
Verna, Goa-403722, India 

PRINCIPAL DISPLAY PANEL

NDC: 25000-075-76

Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg

14 count bottle label

NDC: 25000-075-76

Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg

14 count carton label

NDC: 25000-112-76

Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg (Mini capsules)

14 count bottle label

NDC: 25000-112-76

Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg (Mini capsules)

14 count carton label

INGREDIENTS AND APPEARANCE

ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES, 20 MG 
esomeprazole magnesium delayed-release capsules, 20 mg capsule, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 25000-075
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT)	ESOMEPRAZOLE	20 mg

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
TALC (UNII: 7SEV7J4R1U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
MAGNESIUM STEARATE (UNII: 70097M6I30)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
SHELLAC (UNII: 46N107B71O)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
STARCH, CORN (UNII: O8232NY3SJ)
SUCROSE (UNII: C151H8M554)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
DIMETHICONE (UNII: 92RU3N3Y1O)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)

Product Characteristics
Color	PURPLE (golden cap and violet transparent body having light violet to violet colour band)	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	75
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 25000-075-76	1 in 1 CARTON	09/30/2023
1		14 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA217264	09/30/2023

ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE 20 MG MINI 
esomeprazole magnesium delayed-release 20 mg mini capsule, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 25000-112
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT)	ESOMEPRAZOLE	20 mg

Inactive Ingredients
Ingredient Name	Strength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
STARCH, CORN (UNII: O8232NY3SJ)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
SHELLAC (UNII: 46N107B71O)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Characteristics
Color	YELLOW (golden yellow opaque cap, transparent body, light violet to violet color band)	Score	no score
Shape	CAPSULE	Size	11mm
Flavor		Imprint Code	112
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 25000-112-76	1 in 1 CARTON	03/18/2024
1		14 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA217264	03/18/2024

Labeler - MARKSANS PHARMA LIMITED (925822975)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		925822975	MANUFACTURE(25000-075, 25000-112)