ESOMEPRAZOLE- esomeprazole magnesium capsule, delayed release

Esomeprazole by

Drug Labeling and Warnings

Esomeprazole by is a Otc medication manufactured, distributed, or labeled by INNOVUS PHARMACEUTICALS, INC., Ohm Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each capsule)

*Esomeprazole 20 mg (Each delayed-release capsule contains 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:
  • 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

PREGNANCY OR BREAST FEEDING

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 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.
• Store at 20°C to 25°C (68°F to 77°F). [See USP controlled room temperature.]
• keep the carton. It contains important information.

Inactive Ingredients

FD & C blue no 1, FD & C red no 3, ferrosoferric oxide, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer dispersion, mono and di glycerides, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sugar spheres (corn starch and sucrose), talc, titanium dioxide and triethyl citrate.

Questions?

Call toll-free weekdays 8:30 AM to 5 PM EST at 1-800-818-4555.

TAMPER-EVIDENT FEATURES: Do not use if seal under bottle cap imprinted with "SEALED for YOUR PROTECTION" or blue band around center of each capsule is broken or missing.

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:
Innovus Pharmaceuticals, Inc
Englewood, CO 80112

PRINCIPAL DISPLAY PANEL - 42 Capsule Bottle Carton

†Compare to active ingredient of Nexium® 24HR

NDC: 57483-900-42

Crcle™

Heartburn
Relief

EsomepraCare®
Esomeprazole Magnesium
Delayed-Release Capsules
20 mg* USP / Acid Reducer

24
hour
Treats Frequent Heartburn

42 CAPSULES
Three 14-Day courses of treatment
May take 1 to 4 days for full effect

TRIPLE PACK 3X14 count bottles inside

INGREDIENTS AND APPEARANCE

ESOMEPRAZOLE 
esomeprazole magnesium capsule, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57483-900
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
STARCH, CORN (UNII: O8232NY3SJ)
SUCROSE (UNII: C151H8M554)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)

Product Characteristics
Color	PINK	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	RG;50
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57483-900-42	3 in 1 CARTON	08/14/2020
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	ANDA212866	08/14/2020

Labeler - INNOVUS PHARMACEUTICALS, INC. (962507187)

Establishment
Name	Address	ID/FEI	Business Operations
Ohm Laboratories Inc.		184769029	MANUFACTURE(57483-900)