Label: GOOD SENSE ESOMEPRAZOLE MAGNESIUM- esomeprazole capsule, delayed release
- NDC Code(s): 0113-0898-01, 0113-0898-02, 0113-0898-03
- Packager: L. Perrigo Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated December 5, 2022
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- Active ingredient (in each capsule)
Allergy alert: Do not use if you are allergic to esomeprazole
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
- 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.
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
- Keep out of reach of children.
- 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
- Inactive ingredients
- Questions or comments?
Package/Label Principal Display Panel
See New Warning Information
Delayed-Release Capsules 20 mg
Treats Frequent Heartburn
May Take 1 to 4 Days for Full Effect
Compare to active ingredient of Nexium® 24 HR
100% SATISFACTION GUARANTEED
Three 14-Day Courses of Treatment
INGREDIENTS AND APPEARANCE
GOOD SENSE ESOMEPRAZOLE MAGNESIUM
esomeprazole capsule, delayed release
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0113-0898 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ESOMEPRAZOLE (UNII: N3PA6559FT) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE 20 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 3 (UNII: PN2ZH5LOQY) FERRIC OXIDE RED (UNII: 1K09F3G675) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MEGLUMINE (UNII: 6HG8UB2MUY) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SHELLAC (UNII: 46N107B71O) Product Characteristics Color BLUE (opaque) Score no score Shape CAPSULE (oblong) Size 14mm Flavor Imprint Code L898 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0113-0898-01 1 in 1 CARTON 09/22/2017 1 14 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0113-0898-02 2 in 1 CARTON 09/22/2017 2 14 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:0113-0898-03 3 in 1 CARTON 09/22/2017 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 ANDA207193 09/22/2017 Labeler - L. Perrigo Company (006013346)