Label: OMEPRAZOLE 20 MG tablet, delayed release
- NDC Code(s): 25000-091-76, 25000-091-77
- Packager: MARKSANS PHARMA LIMITED
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 11, 2025
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT(S)
- PURPOSE
- USE(S)
- 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 A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF
- STOP USE AND ASK DOCTOR IF
- PREGNANCY/BREASTFEEDING
- KEEP OUT OF REACH OF CHILDREN
-
DIRECTIONS
Directions
- for adults 18 years of age and older
- this product is to be used once a day (every 24 hours), every day for 14 days
- 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
- swallow 1 tablet with a glass of water before eating in the morning
- take every day for 14 days
- do not take more than 1 tablet a day
- do not use for more than 14 days unless directed by your doctor
- swallow whole. Do not chew or crush tablets.
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. Heartburn in children may sometimes be caused by a serious condition.
- STORAGE
-
INACTIVE INGREDIENTS
Inactive ingredients
colloidal silicone dioxide, crospovidone, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol 400, polyethylene glycol 6000, polysorbate 80, red iron oxide, simethicone, sodium stearyl fumarate, starch, sucrose, talc, titanium dioxide, triethyl citrate
-
QUESTIONS OR COMMENTS
Questions or comments? Call 1-877-376-4271 (weekdays 9 AM to 5 PM)
Tips for Managing Heartburn
• Do not lie flat or bend over after eating.
• Do not wear tight-fitting clothing around the stomach.
• Do not eat before bedtime.
• Raise the head of your bed.
• Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol and certain fruits and vegetables.
• Eat slowly and do not eat big meals.
• If overweight, lose weight.
• Quit smoking.
Manufactured for:
Time-Cap Labs, Inc.
7 Michael Avenue,
Farmingdale,
NY 11735, USA
Manufactured by:
Marksans Pharma Ltd.
Plot No. L-82, L-83
Verna Indl. Estate
Verna, Goa-403722, India
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
OMEPRAZOLE 20 MG
omeprazole 20 mg tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:25000-091 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OMEPRAZOLE MAGNESIUM (UNII: 426QFE7XLK) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE 20 mg Inactive Ingredients Ingredient Name Strength GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE) POLYSORBATE 80 (UNII: 6OZP39ZG8H) FERRIC OXIDE RED (UNII: 1K09F3G675) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) STARCH, CORN (UNII: O8232NY3SJ) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color PINK Score no score Shape OVAL Size 14mm Flavor Imprint Code 91 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:25000-091-77 2 in 1 CARTON 08/12/2025 1 7 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:25000-091-76 1 in 1 CARTON 08/12/2025 2 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 ANDA218829 08/12/2025 Labeler - MARKSANS PHARMA LIMITED (925822975) Establishment Name Address ID/FEI Business Operations MARKSANS PHARMA LIMITED 925822975 MANUFACTURE(25000-091)



