OMEPRAZOLE- omeprazole capsule, delayed release 
Ohm Laboratories Inc.

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Omeprazole

Drug Facts

Active ingredient (in each capsule)

*Omeprazole delayed-release capsule 20 mg (equivalent to 20.6 mg omeprazole magnesium, USP)

Purpose

Acid reducer

Use

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 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 right away (1-800-222-1222).

Directions

Other information

Inactive ingredients

FD&C blue #1, FD&C red #40, ferrosoferric oxide, gelatin, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium stearate, methacrylic acid copolymer, mono and di glycerides, polyethylene glycol 6000, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sodium stearyl fumarate, sugar spheres (starch and sucrose), talc, titanium dioxide and triethyl citrate

Questions?

Call toll-free Monday to Friday 8:30 am to 5 pm EST at 1800-406-7984.

Distributed by:
Ohm Laboratories Inc.
New Brunswick, NJ 08901

PRINCIPAL DISPLAY PANEL - 20 mg Capsule Bottle Carton

Compare To
the active ingredient of
Prilosec OTC®

NDC 51660-061-27

2x14 COUNT BOTTLE INSIDE

Treats FREQUENT Heartburn!
24
HR

Omeprazole
Delayed-release Capsules
20 mg* / Acid Reducer

ohm®

28 CAPSULES
Two 14-day courses of treatment
May take 1 to 4 days for full effect

PRINCIPAL DISPLAY PANEL - 20 mg Capsule Bottle Carton
OMEPRAZOLE 
omeprazole capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51660-061
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEPRAZOLE MAGNESIUM (UNII: 426QFE7XLK) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20.6 mg
Inactive Ingredients
Ingredient NameStrength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
HYDROXYPROPYL CELLULOSE (70000 WAMW) (UNII: 66O7AQV0RT)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
STARCH, CORN (UNII: O8232NY3SJ)  
SUCROSE (UNII: C151H8M554)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code RG;49
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51660-061-443 in 1 CARTON07/21/2018
114 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:51660-061-272 in 1 CARTON07/21/2018
214 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:51660-061-141 in 1 CARTON07/21/2018
314 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21059307/21/2018
Labeler - Ohm Laboratories Inc. (184769029)
Registrant - Ohm Laboratories Inc. (184769029)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.184769029MANUFACTURE(51660-061)
Establishment
NameAddressID/FEIBusiness Operations
Srini Pharmaceuticals Private Limited725914795API MANUFACTURE(51660-061)

Revised: 5/2019
Document Id: 0ae27ef3-b66f-469b-a0de-6cdd0a3a3a3f
Set id: 4c6b6230-ad1f-478c-b69e-aef27ecf61e9
Version: 3
Effective Time: 20190507
 
Ohm Laboratories Inc.