Esomeprazole Magnesium Delayed-release Capsules Usp, 20 Mg (otc)
d2554c3d-eb0b-4bf8-aebc-18be7b195c8e
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Esomeprazole 20 mg (*Each delayed-release capsule corresponds to 22.25 mg esomeprazole magnesium trihydrate USP).
Purpose
Acid reducer
Medication Information
Purpose
Acid reducer
Description
Esomeprazole 20 mg (*Each delayed-release capsule corresponds to 22.25 mg esomeprazole magnesium trihydrate USP).
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 may include:
- skin reddening
. blisters
.rash
If an allergic reaction occurs, stop use and seek medical help 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)
Inactive Ingredients
Black iron oxide, FD&C Blue No. 1, FD&C Blue No. 2, gelatin, glyceryl monostearate, hydroxy propyl cellulose, hypromellose, magnesium stearate, methacrylic acid ethyl acrylate copolymer, potassium hydroxide, polysorbate 80, propylene glycol, shellac, simethicone, sodium lauryl sulfate, strong ammonia solution, sugar spheres (contains sucrose and corn starch), talc, titanium dioxide, triethyl citrate.
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.
Questions Or Comments?
call toll-free weekdays 9 AM to 5 PM EST at 1-888-588-1418.
Distributed by:
Camber Consumer Care, Inc.
Piscataway, NJ 08854, USA.
Principal Display Panel
Esomeprazole Magnesium Delayed-Release Capsules, USP, 20 mg - Carton (Hetero)
Esomeprazole Magnesium Delayed-Release Capsules, USP, 20 mg - Carton (Annora)
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.
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
Active Ingredient (in Each Capsule)
Esomeprazole 20 mg
(*Each delayed-release capsule corresponds to 22.25 mg esomeprazole magnesium trihydrate USP).
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.
Structured Label Content
Uses (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.
Purpose (PURPOSE)
Acid reducer
Warnings (WARNINGS)
Allergy alert:
- Do not use if you are allergic to esomeprazole.
- Esomeprazole may cause severe skin reactions. Symptoms may include:
- skin reddening
. blisters
.rash
If an allergic reaction occurs, stop use and seek medical help right away.
Directions (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 (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)
Inactive Ingredients (INACTIVE INGREDIENTS)
Black iron oxide, FD&C Blue No. 1, FD&C Blue No. 2, gelatin, glyceryl monostearate, hydroxy propyl cellulose, hypromellose, magnesium stearate, methacrylic acid ethyl acrylate copolymer, potassium hydroxide, polysorbate 80, propylene glycol, shellac, simethicone, sodium lauryl sulfate, strong ammonia solution, sugar spheres (contains sucrose and corn starch), talc, titanium dioxide, triethyl citrate.
Do Not Use If You Have (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.
Questions Or Comments? (QUESTIONS OR COMMENTS?)
call toll-free weekdays 9 AM to 5 PM EST at 1-888-588-1418.
Distributed by:
Camber Consumer Care, Inc.
Piscataway, NJ 08854, USA.
Principal Display Panel (PRINCIPAL DISPLAY PANEL)
Esomeprazole Magnesium Delayed-Release Capsules, USP, 20 mg - Carton (Hetero)
Esomeprazole Magnesium Delayed-Release Capsules, USP, 20 mg - Carton (Annora)
If Pregnant 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.
Stop Use and Ask A doctor If (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
Active Ingredient (in Each Capsule) (ACTIVE INGREDIENT (in each capsule))
Esomeprazole 20 mg
(*Each delayed-release capsule corresponds to 22.25 mg esomeprazole magnesium trihydrate USP).
Ask A Doctor Before Use If You Have (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 (ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE)
- taking a prescription drug. Acid reducers may interact with certain prescription drugs.
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T12:05:52.983270 · Updated: 2026-03-14T23:08:17.487612