Label: ESOMEPRAZOLE- esomeprazole magnesium capsule, delayed release
- NDC Code(s): 63941-999-14, 63941-999-42
- Packager: VALU MERCHANDISERS COMPANY
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 3, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each capsule)
- Purpose
- Use
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Warnings
Allergy alert:
- ▪
- Do not use if you are allergic to esomeprazole
- ▪
- Esomeprazole may cause severe skin reactions. Symptoms include:
- ▪
- skin reddening
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- blisters
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- 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
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- heartburn with lightheadedness, sweating or dizziness
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- chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
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- frequent chest pain
These may be signs of a serious condition. See your doctor.
- Ask a doctor or pharmacist before use if you are
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
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Directions
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- adults 18 years of age and older
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- this product is to be used once a day (every 24 hours), every day for 14 days
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- may take 1 to 4 days for full effect
14-Day Course of Treatment
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- swallow 1 capsule with a glass of water before eating in the morning
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- take every day for 14 days
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- do not take more than 1 capsule a day
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- swallow whole. Do not crush or chew capsules.
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- do not use for more than 14 days unless directed by your doctor
- Repeated 14-Day Courses (if needed)
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- you may repeat a 14-day course every 4 months
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- do not take for more than 14 days or more often than every 4 months unless directed by a doctor
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- children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition.
- Other information
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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.
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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
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- 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.
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- Eat slowly and do not eat big meals.
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- Do not eat late at night or just before bedtime.
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- Do not lie flat or bend over soon after eating.
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- Raise the head of your bed.
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- Wear loose-fitting clothing around your stomach.
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- If you are overweight, lose weight.
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- If you smoke, quit smoking.
PROUDLY DISTRIBUTED BY:
ASSOCIATED WHOLESALE GROCERS, INC.
KANSAS ClTY, KANSAS 661061023
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PRINCIPAL DISPLAY PANEL - 20 mg Capsule Bottle Carton
Best
Choice®Compare to the
active ingredient in
Nexium® 24HR*See new warning information
ACID REDUCER
Esomeprazole
MagnesiumDELAYED-RELEASE CAPSULES
USP, 20 mg†24
HOURTreats Frequent
HeartburnMay take 1 to 4 days
for full effect42
CAPSULESThree 14-day courses of treatment
3 x 14 Count Bottles Inside -
INGREDIENTS AND APPEARANCE
ESOMEPRAZOLE
esomeprazole magnesium capsule, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63941-999 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 FERROSOFERRIC OXIDE (UNII: XM0M87F357) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) HYPROMELLOSE 2910 (10000 MPA.S) (UNII: 0HO1H52958) 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 MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ) 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:63941-999-42 3 in 1 CARTON 08/14/2020 1 14 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:63941-999-14 1 in 1 CARTON 08/14/2020 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 ANDA212866 08/14/2020 Labeler - VALU MERCHANDISERS COMPANY (868703513) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 184769029 MANUFACTURE(63941-999) Establishment Name Address ID/FEI Business Operations Sun Pharmaceutical Industries Limited 918591058 API MANUFACTURE(63941-999)