OMEPRAZOLE MAGNESIUM- omeprazole magnesium capsule, delayed release 
Dr. Reddy's Laboratories Limited

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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 a prescription drug.

Acid reducers may interact with certain prescription drugs.

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
  • 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 right away (1-800-222-1222).

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

Revised: 0419

Bottle Label

Dr.Reddy's

NDC 55111-397-52

Treats Frequent Heartburn! 24 HR

Omeprazole

Delayed Release- Capsules

20 mg*

ACID REDUCER

14 Capsules(Safety Sealed)

One 14-Day Course of Treatment

May take 1 to 4 days for full effect

Bottle

Carton Label

Dr.Reddy's

NDC 55111-397-52

Compare to the active ingredient in Prilosec OTC®**

Treats Frequent Heartburn! 24 HR

Omeprazole

Delayed Release- Capsules

20 mg*

ACID REDUCER

14 Capsules(Safety Sealed)

One 14-Day Course of Treatment

May take 1 to 4 days for full effect

Carton

OMEPRAZOLE MAGNESIUM 
omeprazole magnesium capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55111-397
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEPRAZOLE MAGNESIUM (UNII: 426QFE7XLK) (omeprazole - UNII:KG60484QX9) omeprazole20 mg
Inactive Ingredients
Ingredient NameStrength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
HYPROMELLOSE 2208 (3 MPA.S) (UNII: 9H4L916OBU)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2) (UNII: 5KY68S2577)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
RAW SUGAR (UNII: 8M707QY5GH)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorWHITE, PINKScoreno score
ShapeCAPSULESize22mm
FlavorImprint Code OMP20
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55111-397-521 in 1 CARTON03/01/2010
114 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:55111-397-272 in 1 CARTON03/01/2010
214 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:55111-397-333 in 1 CARTON03/01/2010
314 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:55111-397-393 in 1 CARTON09/01/2015
414 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:55111-397-282 in 1 CARTON03/01/2010
5NDC:55111-397-742 in 1 CARTON
57 in 1 BLISTER PACK; Type 0: Not a Combination Product
6NDC:55111-397-423 in 1 CARTON03/01/2010
6NDC:55111-397-742 in 1 CARTON
67 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07887803/01/2010
Labeler - Dr. Reddy's Laboratories Limited (650562841)

Revised: 5/2019
Document Id: 41f88be5-fb44-24af-30db-543aacb1a040
Set id: 0e8fde83-a55c-edaf-3c66-e1fc77d0bc11
Version: 19
Effective Time: 20190503
 
Dr. Reddy's Laboratories Limited