Omeprazole 20 Mg Tablet, Delayed Release
FDA Label NDC 25000-094

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

Purpose 

Acid reducer

Use
• 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
Allergy alert: 
• Do not use if you are allergic to omeprazole.
• Omeprazole may cause severe skin reactions. Symptoms may include:
      o skin reddening
      o blisters
      o rash
If an allergic reaction occurs, stop use and seek medical help right away. 

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 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 you are taking a prescription drug. 
Acid reducers may interact with certain prescription drugs.

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

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 (1-800-222-1222) right away. 

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
     o swallow 1 tablet with a glass of water before eating in the morning
     o take every day for 14 days
     o do not take more than 1 tablet a day
     o do not use for more than 14 days unless directed by your doctor
     o swallow whole. Do not chew, crush, or suck tablets.

  Repeated 14-Day Courses (if needed)
     o you may repeat a 14-day course every 4 months
     o 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.

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

Inactive ingredients colloidal silicon dioxide, crospovidone, ethyl menthane carboxamide, FD and C blue no. 2 Al. lake, FD and C red no. 40 Al. lake, flavor, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, menthol, methacrylic acid and ethyl acrylate copolymer, mica, microcrystalline cellulose, polyethylene glycol 6000, polysorbate 80, propylene glycol, saccharin sodium, simethicone, sodium stearyl fumarate, starch, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

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  

NDC: 25000-094-81
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