Esomeprazole: Package Insert and Label Information

ESOMEPRAZOLE- esomeprazole magnesium capsule, delayed release
Ohm Laboratories Inc.

Active ingredient (in each capsule)

*Esomeprazole 20 mg (Each delayed-release capsule contains 22.3 mg esomeprazole magnesium trihydrate)

Purpose

Acid reducer

Use

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

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.
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:
Ohm Laboratories Inc.
New Brunswick, NJ 08901

R0922

PRINCIPAL DISPLAY PANEL — 42 Capsule Bottle Carton

Compare To
the active ingredient of
Nexium® 24HR

See new warning information

NDC 51660-027-44

Treats Frequent Heartburn
24
HR

Esomeprazole Magnesium
Delayed-Release Capsules
USP, 20 mg* / Acid Reducer
May take 1 to 4 days for full effect

ohm®

42 CAPSULES
Three 14-day courses of treatment

3 x 14 Count Bottles Inside

42ct-carton
(click image for full-size original)
ESOMEPRAZOLE
esomeprazole magnesium capsule, delayed release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51660-027
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE) ESOMEPRAZOLE 20 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE
GELATIN, UNSPECIFIED
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSE 2208 (100 MPA.S)
MAGNESIUM STEARATE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
POLYSORBATE 80
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
STARCH, CORN
SUCROSE
FD&C BLUE NO. 1
FD&C RED NO. 3
GLYCERYL MONOSTEARATE
Product Characteristics
Color PINK Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code RG;50
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51660-027-44 3 BOTTLE in 1 CARTON contains a BOTTLE
1 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE This package is contained within the CARTON (51660-027-44)
2 NDC:51660-027-27 2 BOTTLE in 1 CARTON contains a BOTTLE
2 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE This package is contained within the CARTON (51660-027-27)
3 NDC:51660-027-14 1 BOTTLE in 1 CARTON contains a BOTTLE
3 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE This package is contained within the CARTON (51660-027-14)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212866 08/14/2020
Labeler — Ohm Laboratories Inc. (184769029)
Registrant — Sun Pharmaceutical Industries, Inc. (146974886)
Establishment
Name Address ID/FEI Operations
Ohm Laboratories Inc. 184769029 MANUFACTURE (51660-027)
Establishment
Name Address ID/FEI Operations
Sun Pharmaceutical Industries Limited 918591058 API MANUFACTURE (51660-027)

Revised: 09/2022 Ohm Laboratories Inc.

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