ESOMEPRAZOLE MAGNESIUM capsule, delayed release

ESOMEPRAZOLE MAGNESIUM by

Drug Labeling and Warnings

ESOMEPRAZOLE MAGNESIUM by is a Otc medication manufactured, distributed, or labeled by Rising Pharma Holdings, Inc., Graviti Pharmaceuticals Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Active ingredient (in each capsule)	Purpose
Esomeprazole 20 mg	Acid reducer
(Each delayed-release capsule corresponds to 22.250 mg esomeprazole magnesium trihydrate)

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 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 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° to 25°C (68° to 77°F).

Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg:

FD&C Blue 2, Gelatin, Hydroxypropyl Cellulose, Hypromellose, Magnesium Stearate, Methacrylic Acid and Ethyl Acrylate Copolymer Dispersion, Mono-and Di-Glycerides, Pharmaceutical Ink, Polysorbate 80, Sugar Spheres, Talc, Triethyl Citrate.

Questions or comments?

Call toll-free weekdays 9 AM to 5 PM EST at 1-844-474-7464.

Contact Graviti Pharmaceuticals Inc., or www.gravitipharma.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Made in India

See new warning information

• Treats Frequent Heartburn

Esomeprazole magnesium delayed-release capsules 20 mg/acid reducer

May take 1 to 4 days for full effect

14 CAPSULES

One 14-day course of treatment Capsules

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

ACTIVE INGREDIENT

PURPOSE

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

WARNINGS

DOSAGE & ADMINISTRATION

INACTIVE INGREDIENT

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel - 20 mg Capsules: Container Label

NDC: 16571-880-41

Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg

24 HR

Acid Reducer

Treats Frequent Heartburn

May take 1 to 4 Days for Full effect

14 Capsules

One 14-day Course of Treatment

Distributed by: Rising Pharma Holdings, Inc.

Principal Display Panel - 20 mg Capsules: Carton Label

NDC: 16571-880-41

Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg

24 HR

Acid Reducer

Treats Frequent Heartburn

May take 1 to 4 Days for Full effect

14 Capsules

One 14-day Course of Treatment

Distributed by: Rising Pharma Holdings, Inc.

Principal Display Panel - 20 mg Capsules: Carton Label

NDC: 16571-880-42

Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg

24 HR

Acid Reducer

Treats Frequent Heartburn

May take 1 to 4 Days for Full effect

42 Capsules

Three 14-day Courses of Treatment

Distributed by: Rising Pharma Holdings, Inc.

INGREDIENTS AND APPEARANCE

ESOMEPRAZOLE MAGNESIUM 
esomeprazole magnesium capsule, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 16571-880
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
RAW SUGAR (UNII: 8M707QY5GH)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
TALC (UNII: 7SEV7J4R1U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHACRYLIC ACID-ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERYL DISTEARATE (UNII: 73071MW2KM)

Product Characteristics
Color	WHITE (white opaque colored)	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	20mg;223
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 16571-880-41	1 in 1 CARTON	12/01/2022
1		14 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 16571-880-42	3 in 1 CARTON	12/01/2022
2		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	ANDA216349	12/01/2022

Labeler - Rising Pharma Holdings, Inc. (116880195)

Establishment
Name	Address	ID/FEI	Business Operations
Graviti Pharmaceuticals Private Limited		650884781	MANUFACTURE(16571-880) , ANALYSIS(16571-880)