ESOMEPRAZOLE MAGNESIUM- esomeprazole capsule, delayed release

Esomeprazole Magnesium by

Drug Labeling and Warnings

Esomeprazole Magnesium by is a Otc medication manufactured, distributed, or labeled by Publix Super Markets Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each capsule)

Esomeprazole 20 mg

(Each delayed-release capsule corresponds to 22 mg esomeprazole magnesium dihydrate)

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

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

• warfarin, clopidogrel or cilostazol (blood-thinning medicines)
• prescription antifungal or anti-yeast medicines
• digoxin (heart medicine)
• diazepam (anxiety medicine)
• tacrolimus or mycophenolate mofetil (immune system medicines)
• prescription antiretrovirals (medicines for HIV infection)
• methotrexate (arthritis medicine)

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

• 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

FD&C blue no. 1, FD&C red no. 3, ferric oxide, gelatin, glyceryl monostearate, hypromellose, magnesium stearate, meglumine, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, shellac, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate

Package/Label Principal Display Panel

esomeprazole magnesium

DELAYED-RELEASE CAPSULES, 20 mg ACID REDUCER 24 HOUR

SEE NEW WARNING

CAPSULES

Treats frequent heartburn

May take 1 to 4 days for full effect

Three 14-day courses of treatment

42 CAPSULES

3 BOTTLES INSIDE

ACTUAL SIZE

Compare to Nexium® 24 HR active ingredient

INGREDIENTS AND APPEARANCE

ESOMEPRAZOLE MAGNESIUM 
esomeprazole capsule, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56062-898
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
FERRIC OXIDE RED (UNII: 1K09F3G675)
GELATIN (UNII: 2G86QN327L)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MEGLUMINE (UNII: 6HG8UB2MUY)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SHELLAC (UNII: 46N107B71O)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Characteristics
Color	BLUE (opaque)	Score	no score
Shape	CAPSULE (oblong)	Size	14mm
Flavor		Imprint Code	L898
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56062-898-01	1 in 1 CARTON	09/29/2017
1		14 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 56062-898-02	2 in 1 CARTON	09/29/2017
2		14 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 56062-898-03	3 in 1 CARTON	09/29/2017
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	ANDA207193	09/29/2017

Labeler - Publix Super Markets Inc (006922009)