Label: GOOD SENSE OMEPRAZOLE- omeprazole tablet, delayed release
- NDC Code(s): 0113-1723-01, 0113-1723-03
- Packager: L. Perrigo Company
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated March 24, 2024
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- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Use
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Warnings
Allergy alert:
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- do not use if you are allergic to omeprazole.
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- omeprazole may cause severe skin reactions. Symptoms may include:
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- 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:
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- 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 before use if you have:
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- had heartburn over 3 months. This may be a sign of a more serious condition.
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- frequent wheezing, particularly with heartburn
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- unexplained weight loss
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- nausea or vomiting
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- stomach pain
Ask a doctor or pharmacist before use if you are
taking a prescription drug. Acid reducers may interact with certain prescription drugs.
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Directions
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- for 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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- it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours
14-Day Course of Treatment
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- swallow 1 tablet 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 tablet a day
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- do not use for more than 14 days unless directed by your doctor
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- swallow whole. Do not chew, crush, or suck tablets.
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. Heartburn in children may sometimes be caused by a serious condition.
- Other information
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Inactive ingredients
benzyl alcohol, carmine, carnauba wax, FD&C blue #2/indigo carmine aluminum lake, flavor, hypromellose, hypromellose acetate succinate, lactose monohydrate, menthol, modified starch, monoethanolamine, polyethylene glycol 3350, sodium lauryl sulfate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, sucralose, talc, titanium dioxide, triacetin, triethyl citrate
- Questions or comments?
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Package/Label Principal Display Panel
GOODSENSE®
FDA APPROVED
Treats Frequent Heartburn!
24 HR
Omeprazole Delayed Release Tablets 20 mg
Acid Reducer
20
Wildberry Mint Coated Tablet
Compare to Prilosec OTC®
Actual Size
SWALLOW – DO NOT CHEW
42 Tablets
Three 14-Day Courses of Treatment
May Take 1 to 4 Days For Full Effect
3 Bottles Inside
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INGREDIENTS AND APPEARANCE
GOOD SENSE OMEPRAZOLE
omeprazole tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0113-1723 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE 20 mg Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) CARNAUBA WAX (UNII: R12CBM0EIZ) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) HYPROMELLOSE ACETATE SUCCINATE, UNSPECIFIED (UNII: A7ZHS2RJ34) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) MONOETHANOLAMINE (UNII: 5KV86114PT) POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM STEARATE (UNII: QU7E2XA9TG) SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) SUCRALOSE (UNII: 96K6UQ3ZD4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color PURPLE Score no score Shape OVAL Size 12mm Flavor BERRY Imprint Code 20 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0113-1723-03 3 in 1 CARTON 05/22/2019 1 14 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0113-1723-01 14 in 1 BOTTLE; Type 0: Not a Combination Product 05/22/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022032 05/22/2019 Labeler - L. Perrigo Company (006013346)