Label: ESOMEPRAZOLE MAGNESIUM- esomeprazole magnesium capsule, delayed release
- NDC Code(s): 69230-320-31, 69230-320-32, 69230-320-33
- Packager: Camber Consumer Care Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 25, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT (in each capsule)
- PURPOSE
- USES
- WARNINGS
-
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
- 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 effect14-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
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.
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ESOMEPRAZOLE MAGNESIUM
esomeprazole magnesium capsule, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69230-320 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 TALC (UNII: 7SEV7J4R1U) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) GELATIN (UNII: 2G86QN327L) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) MAGNESIUM STEARATE (UNII: 70097M6I30) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: MB5IUD6JUA) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SUCROSE (UNII: C151H8M554) HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P) AMMONIA (UNII: 5138Q19F1X) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) DIMETHICONE (UNII: 92RU3N3Y1O) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J) HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4) Product Characteristics Color white (white opaque cap) , blue (blue opaque body) Score no score Shape CAPSULE Size 14mm Flavor Imprint Code H;E4 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69230-320-31 1 in 1 CARTON 06/02/2020 1 14 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:69230-320-32 2 in 1 CARTON 06/02/2020 2 14 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:69230-320-33 3 in 1 CARTON 06/02/2020 3 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 ANDA212507 06/02/2020 Labeler - Camber Consumer Care Inc (079539968) Establishment Name Address ID/FEI Business Operations Hetero Labs Limited Unit III 676162024 manufacture(69230-320)