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Omeprazole Magnesium by Dr. Reddy's Laboratories Limited

Medically reviewed on August 8, 2017

Dosage form: capsule, delayed release
Ingredients: OMEPRAZOLE MAGNESIUM 20mg
Labeler: Dr. Reddy's Laboratories Limited
NDC Code: 55111-397

Drug Facts

Active ingredient (in each capsule)

*Omeprazole delayed-release capsules 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 

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:

• warfarin, clopidogrel or cilostazol (blood-thinning medicines)

• prescription antifungal or anti-yeast medicines

• diazepam (anxiety medicine)

• digoxin (heart medicine)

• tacrolimus or mycophenolate mofetil (immune system medicines)

• prescription antiretrovirals (medicines for HIV infection)

• methotrexate (arthritis medicine)

Stop use and ask 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

 

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.

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 capsule with a glass of water before eating in the morning

  • take every day for 14 days

  • do not take more than 1 capsule a day

  • do not use for more than 14 days unless directed by your doctor

  • swallow whole. Do not chew or crush capsules

  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.

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

black iron oxide, dibasic calcium phosphate, gelatin, glyceryl monostearate, hypromellose 3 cps, magnesium oxide, magnesium stearate, methacrylic acid copolymer dispersion, methacrylic acid copolymer Type B, microcrystalline cellulose, polysorbate 80, potassium hydroxide, propylene glycol, red iron oxide, shellac, silicon dioxide, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate

Questions

call 1-888-375-3784

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 avoid big meals
  • If overweight, lose weight
  • Quit smoking

PRINCIPAL DISPLAY PANEL

Container Label:


Container Carton Label

OMEPRAZOLE MAGNESIUM 
omeprazole magnesium capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55111-397
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEPRAZOLE MAGNESIUM (omeprazole) omeprazole20 mg
Inactive Ingredients
Ingredient NameStrength
FERROSOFERRIC OXIDE 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
CARRAGEENAN  
GLYCERYL MONOSTEARATE 
HYPROMELLOSES 
HYPROMELLOSE 2208 (3 MPA.S) 
MAGNESIUM OXIDE 
MAGNESIUM STEARATE 
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2) 
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A 
CELLULOSE, MICROCRYSTALLINE 
POTASSIUM CHLORIDE 
POTASSIUM HYDROXIDE 
PROPYLENE GLYCOL 
FERRIC OXIDE RED 
SHELLAC 
SILICON DIOXIDE 
RAW SUGAR 
TALC 
TITANIUM DIOXIDE 
TRIETHYL CITRATE 
Product Characteristics
ColorWHITE, PINKScoreno score
ShapeCAPSULESize22mm
FlavorImprint CodeOMP20
Contains    
Packaging
#Item CodePackage Description
1NDC:55111-397-521 BOTTLE in 1 CARTON
114 CAPSULE, DELAYED RELEASE in 1 BOTTLE
2NDC:55111-397-272 BOTTLE in 1 CARTON
214 CAPSULE, DELAYED RELEASE in 1 BOTTLE
3NDC:55111-397-333 BOTTLE in 1 CARTON
314 CAPSULE, DELAYED RELEASE in 1 BOTTLE
4NDC:55111-397-393 BOTTLE in 1 CARTON
414 CAPSULE, DELAYED RELEASE in 1 BOTTLE
5NDC:55111-397-282 CARTON in 1 CARTON
5NDC:55111-397-742 BLISTER PACK in 1 CARTON
57 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
6NDC:55111-397-423 CARTON in 1 CARTON
6NDC:55111-397-742 BLISTER PACK in 1 CARTON
67 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07887803/01/2010
Labeler - Dr. Reddy's Laboratories Limited (650562841)

 
Dr. Reddy's Laboratories Limited

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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