Label: ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES, 20 MG capsule, delayed release
ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE 20 MG MINI capsule, delayed release
- NDC Code(s): 25000-075-76, 25000-112-76
- Packager: MARKSANS PHARMA LIMITED
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 18, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each capsule)
- Purpose
- Uses
- Warnings
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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 painThese may be signs of a serious condition. See your doctor.
- Ask a doctor before use if you have
- 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
- 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 doctorRepeated 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
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Inactive ingredients
Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg
Inactive ingredients black iron oxide, eudragit, FD&C Blue 1, FD&C Red 3, ferric oxide yellow, gelatin, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, polysorbate 80, potassium hydroxide, shellac, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate.
Esomeprazole Magnesium Delayed-Release Capsules 20 mg (Mini Capsules)
Inactive ingredients black iron oxide, corn starch, D&C red 27 aluminum lake, eudragit, FD&C blue 1, FD&C red 3, ferric oxide yellow, gelatin, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, polysorbate 80, potassium hydroxide, shellac, simethicone, sodium lauryl sulfate, sucrose, talc, titanium dioxide, triethyl citrate
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Questions or comments
Call 1-877-376-4271 (weekdays 9 AM to 5 PM)
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.
Manufactured for:
Time-Cap Labs, Inc.
7 Michael Avenue,
Farmingdale,
NY 11735, USA
Manufactured by:
Marksans Pharma Ltd.
Plot No. L-82, L-83
Verna Indl. Estate
Verna, Goa-403722, India -
PRINCIPAL DISPLAY PANEL
NDC: 25000-075-76
Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg
14 count bottle label
NDC: 25000-075-76
Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg
14 count carton label
NDC: 25000-112-76
Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg (Mini capsules)
14 count bottle label
NDC: 25000-112-76
Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg (Mini capsules)
14 count carton label
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INGREDIENTS AND APPEARANCE
ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES, 20 MG
esomeprazole magnesium delayed-release capsules, 20 mg capsule, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:25000-075 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 HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) TALC (UNII: 7SEV7J4R1U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) MAGNESIUM STEARATE (UNII: 70097M6I30) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FD&C RED NO. 3 (UNII: PN2ZH5LOQY) SHELLAC (UNII: 46N107B71O) FERROSOFERRIC OXIDE (UNII: XM0M87F357) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) STARCH, CORN (UNII: O8232NY3SJ) SUCROSE (UNII: C151H8M554) SODIUM LAURYL SULFATE (UNII: 368GB5141J) DIMETHICONE (UNII: 92RU3N3Y1O) METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J) Product Characteristics Color PURPLE (golden cap and violet transparent body having light violet to violet colour band) Score no score Shape CAPSULE Size 14mm Flavor Imprint Code 75 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:25000-075-76 1 in 1 CARTON 09/30/2023 1 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 ANDA217264 09/30/2023 ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE 20 MG MINI
esomeprazole magnesium delayed-release 20 mg mini capsule, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:25000-112 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) STARCH, CORN (UNII: O8232NY3SJ) D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX) METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 3 (UNII: PN2ZH5LOQY) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) SHELLAC (UNII: 46N107B71O) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color YELLOW (golden yellow opaque cap, transparent body, light violet to violet color band) Score no score Shape CAPSULE Size 11mm Flavor Imprint Code 112 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:25000-112-76 1 in 1 CARTON 03/18/2024 1 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 ANDA217264 03/18/2024 Labeler - MARKSANS PHARMA LIMITED (925822975) Establishment Name Address ID/FEI Business Operations MARKSANS PHARMA LIMITED 925822975 MANUFACTURE(25000-075, 25000-112)