Label: ESOMEPRAZOLE MAGNESIUM capsule, delayed release
- NDC Code(s): 49483-718-41
- Packager: TIME CAP LABORATORIES, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 23, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
-
DO NOT USE
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 DOCTOR
- ASK DOCTOR/PHARMACIST
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
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 SAFETY INFORMATION
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INACTIVE INGREDIENT
Inactive ingredientsblack 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.
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INGREDIENTS AND APPEARANCE
ESOMEPRAZOLE MAGNESIUM
esomeprazole magnesium capsule, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49483-718 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 SUCROSE (UNII: C151H8M554) DIMETHICONE (UNII: 92RU3N3Y1O) FERROSOFERRIC OXIDE (UNII: XM0M87F357) METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13) HYPROMELLOSES (UNII: 3NXW29V3WO) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SHELLAC (UNII: 46N107B71O) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) FD&C RED NO. 3 (UNII: PN2ZH5LOQY) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color purple (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:49483-718-41 3 in 1 CARTON 11/14/2023 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 11/14/2023 Labeler - TIME CAP LABORATORIES, INC. (037052099) Registrant - TIME CAP LABORATORIES, INC. (037052099) Establishment Name Address ID/FEI Business Operations MARKSANS PHARMA LIMITED 925822975 manufacture(49483-718)