Acid Reducer: Package Insert and Label Information

ACID REDUCER- esomeprazole magnesium tablet, delayed release
Cardinal Health (Leader) 70000

Drug Facts

Active ingredient (in each tablet)

Esomeprazole 20 mg
(*Each delayed-release tablet corresponds to 22.25 mg esomeprazole magnesium, USP (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

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

  • 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 (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 tablet with a glass of water before eating in the morning
• take every day for 14 days
• do not take more than 1 tablet a day
• swallow whole. Do not crush or chew tablets.
• 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 us
  • keep the carton. It contains important information.
  • store at 20° to 25°C (68° to 77°F)

Inactive ingredients

black iron oxide, colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, low substituted hydroxypropyl cellulose, magnesium stearate, methacrylic acid — ethyl acrylate copolymer dispersion, microcrystalline cellulose, mono-and di-glycerides, polyethylene glycol, polysorbate 80, propylene glycol, red iron oxide, shellac glaze, sodium lauryl sulfate, sodium stearyl fumarate, sugar spheres (corn starch and sucrose), talc, titanium dioxide, triethyl citrate and yellow iron oxide

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO NEXIUM® 24 HR active ingredient†

SEE NEW WARNING INFORMATION

24-hour

Esomeprazole Magnesium

Delayed-Release Tablets, 20 mg* | Acid Reducer

Treats Frequent Heartburn

May Take 1 to 4 days for Full Effect

TABLETS

One 14-Day Course of Treatment

†This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Nexium® 24HR.

TAMPER EVIDENT: DO NOT USE IF SEAL UNDER BOTTLE CAP BROKEN OR MISSING.

KEEP CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

Package label

Esomeprazole 20 mg (*Each delayed-release tablet corresponds to 22.25 mg esomeprazole magnesium, USP (trihydrate))
(click image for full-size original)

LEADER Acid Reducer

ACID REDUCER
esomeprazole magnesium tablet, delayed release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0095
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
SILICON DIOXIDE
HYPROMELLOSE, UNSPECIFIED
GLYCERYL MONO AND DIPALMITOSTEARATE
MAGNESIUM STEARATE
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
POLYSORBATE 80
SODIUM LAURYL SULFATE
SUCROSE
STARCH, CORN
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
CROSPOVIDONE
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
PROPYLENE GLYCOL
SHELLAC
SODIUM STEARYL FUMARATE
FERROSOFERRIC OXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
Product Characteristics
Color pink Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code EL
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70000-0095-1 1 BOTTLE in 1 CARTON contains a BOTTLE
1 14 TABLET, DELAYED RELEASE in 1 BOTTLE This package is contained within the CARTON (70000-0095-1)
2 NDC:70000-0095-2 3 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
2 1 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC This package is contained within the CARTON (70000-0095-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212088 04/30/2021
Labeler — Cardinal Health (Leader) 70000 (063997360)

Revised: 05/2021 Cardinal Health (Leader) 70000

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