OMEPRAZOLE 20 MG tablet, delayed release

Omeprazole 20 mg by

Drug Labeling and Warnings

Omeprazole 20 mg by is a Otc medication manufactured, distributed, or labeled by MARKSANS PHARMA LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(S)

Active ingredient (in each tablet)                                         
Omeprazole, USP 20 mg 
(equivalent to 20.6 mg omeprazole magnesium)

PURPOSE

Purpose 
Acid reducer

USE(S)

Uses
 treats frequent heartburn (occurs 2 or more days a week)
 not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

WARNINGS

Warnings
Allergy alert: 

• Do not use if you are allergic to Omeprazole

• Omeprazole may cause severe skin reactions. Symptoms include:
  • skin reddening
  • blisters
  • rash
  If an allergic reaction occurs, stop use and seek medical attention right away.

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 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

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 DOCTOR IF

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

PREGNANCY/BREASTFEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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).

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

Other information

• read the directions and warnings before use
• keep the carton. It contains important information.
• store at 20-25°C (68-77°F) and protect from moisture

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

NDC: 25000-091-76
Omeprazole Delayed-Release Tablets 20 mg 
14's count Carton 

NDC: 25000-091-76
Omeprazole Delayed-Release Tablets 20 mg 
14's count Label 

NDC: 25000-091-77
Omeprazole Delayed-Release Tablets 20 mg 
14's count (2 x 7's blister) Carton

INGREDIENTS AND APPEARANCE

OMEPRAZOLE 20 MG 
omeprazole 20 mg tablet, delayed release

Product 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)