ESOMEPRAZOLE MAGNESIUM tablet, delayed release

Esomeprazole Magnesium by

Drug Labeling and Warnings

Esomeprazole Magnesium by is a Otc medication manufactured, distributed, or labeled by Aurohealth LLC, Aurobindo Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)

*Esomeprazole 20 mg
(Each film-coated delayed-release tablet corresponds to 21.75 mg esomeprazole magnesium dihydrate USP)

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 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

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

• 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 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
• 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° to 25°C (68° to 77°F)

Inactive ingredients

colloidal silicon dioxide, crospovidone, hydroxy propyl cellulose, hypromellose, low substituted hydroxy propyl cellulose, magnesium carbonate, magnesium oxide, methacrylic acid and ethyl acrylate copolymer dispersion (which contains copolymer based on ethyl acrylate and methacrylic acid, polysorbate 80 and sodium lauryl sulfate), microcrystalline cellulose, mono and di-glycerides, polyethylene glycol, polysorbate 80, red iron oxide, sodium stearyl fumarate, sugar spheres [which contains liquid glucose, starch (maize) and sucrose], talc, titanium dioxide, triethyl citrate and yellow iron oxide. 

Questions or comments? call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)

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.

Distributed by:  
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Made in India  

Code: TS/DRUGS/22/2009      

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablets)

AUROHEALTH

NDC: 58602-840-05

Esomeprazole Magnesium
Delayed-Release Tablets 20 mg*

Acid Reducer
24 HR

May take 1 to 4 days for full effect
Treats Frequent Heartburn
14 Tablets
One 14-day course of treatment

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablets)

#Compare to Nexium® 24 HR
Active ingredient

AUROHEALTH

NDC: 58602-840-05
See new warning information

Esomeprazole Magnesium
Delayed-Release 
Tablets 20 mg*

Acid Reducer
24 HR

Treats Frequent Heartburn

May take 1 to 4 days for full effect
14 Tablets
One 14-day course of treatment

INGREDIENTS AND APPEARANCE

ESOMEPRAZOLE MAGNESIUM 
esomeprazole magnesium tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-840
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ESOMEPRAZOLE MAGNESIUM DIHYDRATE (UNII: 36H71644EQ) (ESOMEPRAZOLE - UNII:N3PA6559FT)	ESOMEPRAZOLE	20 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)
HYDROXYPROPYL CELLULOSE (20000 WAMW) (UNII: KZQ570MOA5)
HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 130000 MW) (UNII: 7773C1ROEU)
MAGNESIUM CARBONATE (UNII: 0E53J927NA)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
MICROCRYSTALLINE CELLULOSE 301 (UNII: W7YXH6D4BD)
MICROCRYSTALLINE CELLULOSE 302 (UNII: 91B875MM4H)
GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
STARCH, CORN (UNII: O8232NY3SJ)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Product Characteristics
Color	PINK (Light pink)	Score	no score
Shape	OVAL (Oblong, Biconvex)	Size	13mm
Flavor		Imprint Code	K;12
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-840-05	1 in 1 CARTON	07/12/2023
1		14 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 58602-840-61	2 in 1 CARTON	07/12/2023
2		14 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 58602-840-62	3 in 1 CARTON	07/12/2023
3		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	ANDA214473	07/12/2023

Labeler - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurobindo Pharma Limited		650381903	ANALYSIS(58602-840) , MANUFACTURE(58602-840)