Active Ingredient(S)
Active ingredient (in each tablet)
Omeprazole, USP 20 mg
(equivalent to 20.6 mg omeprazole magnesium)
Omeprazole 20 Mg Tablet, Delayed Release
FDA Label NDC 25000-091
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Marksans Pharma Limited for the product Omeprazole 20 Mg (NDC 25000-091). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient(s), purpose, use(s), warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if, stop use and ask doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
- 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.
- 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.
14-Day Course of Treatment
Repeated 14-Day Courses (if needed)
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
Omeprazole-14s-blister-carton (Omeprazole 14s Bottle Pack Carton)
NDC: 25000-091-76
Omeprazole Delayed-Release Tablets 20 mg
14's count Label
Omeprazole-14s-bottle-pack-label (Omeprazole 14s Bottle Pack Label)
NDC: 25000-091-77
Omeprazole Delayed-Release Tablets 20 mg
14's count (2 x 7's blister) Carton
Omeprazole-14s-blisterpack-carton (Omeprazole 14s Blisterpack Carton)
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