Label: OMEPRAZOLE tablet, delayed release
- NDC Code(s): 30142-992-14, 30142-992-28
- Packager: THE KROGER COMPANY
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 6, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Keep Out of Reach of Children
- Uses
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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.
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.
Stop use and ask a doctor if:
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- your heartburn continues or worsens
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- you need to take this product for more than 14 days
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- you need to take more than 1 course of treatment every 4 months
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- you get diarrhea
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- you develop a rash or joint pain
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
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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 or crush 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
anhydrous lactose, hypromellose, hypromellose acetate succinate, iron oxide red, iron oxide yellow, lactose monohydrate, methyl cellulose, monoethanolamine, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, talc, triethyl citrate and titanium dioxide.
The imprinting ink contains ammonium hydroxide, black iron oxide, n-butyl alcohol, propylene glycol and shellac.
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PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Carton
COMPARE TO PRILOSEC OTC® *See bottom panel
NDC 30142-992-28
Kroger®
See new warning information
Omeprazole
Delayed-release
Tablets 20 mgACID REDUCER
SWALLOW- DO NOT CHEW
OUR PHARMACIST RECOMMENDED
Treats FREQUENT Heartburn!
24 HR
28 TABLETS
Two 14-Day Courses of Treatment
May Take 1 to 4 Days for Full Effectactual size
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INGREDIENTS AND APPEARANCE
OMEPRAZOLE
omeprazole tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-992 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 ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MM2/S) (UNII: 36BGF0E889) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MONOETHANOLAMINE (UNII: 5KV86114PT) METHYLCELLULOSE (1500 MPA.S) (UNII: P0NTE48364) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) SODIUM STEARATE (UNII: QU7E2XA9TG) SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) AMMONIA (UNII: 5138Q19F1X) FERROSOFERRIC OXIDE (UNII: XM0M87F357) BUTYL ALCOHOL (UNII: 8PJ61P6TS3) SHELLAC (UNII: 46N107B71O) Product Characteristics Color BROWN (brownish pink) Score no score Shape OVAL (bioconvex) Size 12mm Flavor Imprint Code 20 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30142-992-14 14 in 1 BOTTLE; Type 0: Not a Combination Product 07/15/2020 2 NDC:30142-992-28 2 in 1 CARTON; Type 0: Not a Combination Product 07/15/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207891 07/15/2020 Labeler - THE KROGER COMPANY (006999528) Establishment Name Address ID/FEI Business Operations Sun Pharmaceutical Industries Limited 650445203 MANUFACTURE(30142-992)