ESOMEPRAZOLE MAGNESIUM- esomeprazole magnesium capsule, delayed release capsule

Esomeprazole Magnesium by

Drug Labeling and Warnings

Esomeprazole Magnesium by is a Otc medication manufactured, distributed, or labeled by Allegiant Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient(s)

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

Purpose

Acid reducer

Use(s)

• 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

• 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 breastfeeding,

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)

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.

Inactive ingredients

Black iron oxide, FD&C Blue No. 1, FD&C Blue No. 2, gelatin, glyceryl monostearate, hydroxy propyl cellulose,
hypromellose, magnesium stearate, methacrylic acid ethyl acrylate copolymer, potassium hydroxide,
polysorbate 80, propylene glycol, shellac, simethicone, sodium lauryl sulfate, strong ammonia
solution, sugar spheres (contains sucrose and corn starch), talc, titanium dioxide, triethyl citrate.

Questions/Comments

Call 1-888-952-0050 Monday through Friday
9AM – 5PM EST

Principal Display Panel

Esomeprazole Magnesium Label

Esomeprazole Magnesium 14ct

Esomeprazole Magnesium 42ct

INGREDIENTS AND APPEARANCE

ESOMEPRAZOLE MAGNESIUM 
esomeprazole magnesium capsule, delayed release capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69168-472
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
IRON OXIDES (UNII: 1K09F3G675)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
GELATIN (UNII: 2G86QN327L)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
AMMONIA (UNII: 5138Q19F1X)
SUCROSE (UNII: C151H8M554)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)

Product Characteristics
Color	blue (blue opaque body) , white (white opaque cap)	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	E4;H
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69168-472-14	1 in 1 CARTON	05/15/2025
1		14 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 69168-472-61	1 in 1 CARTON	05/15/2025
2		14 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 69168-472-42	3 in 1 CARTON	05/15/2025
3		14 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 69168-472-62	3 in 1 CARTON	05/15/2025
4		14 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 69168-472-15	14 in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA212507	05/15/2025

Labeler - Allegiant Health (079501930)