OMEPRAZOLE- omeprazole tablet, delayed release 
Dr. Reddys Laboratories Inc

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Omeprazole Delayed Release Tablets

Active ingredient(s)

Omeprazole  USP, 20 mg

Purpose

Acid reducer

Use(s)

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 lightheadednes
  • 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

14-Day Course of Treatment

Repeated 14-Day Courses (if needed)

Other information

Inactive ingredients

ammonia solution, ammonium hydroxide, carnauba wax, hypromellose acetate succinate, hypromellose, iron oxide black, lactose monohydrate, monoethanolamine, n-butyl alcohol, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, red iron oxide, sodium stearate, sodium starch glycolate, shellac glaze, sodium lauryl sulphate, sodium stearyl fumarate, talc, titanium dioxide, triethyl citrate, yellow iron oxide

Questions or comments?

call 1-888-375-3784

Distributed by:

Dr. Reddy’s Laboratories Inc.,

Princeton, NJ 08540

Made in India

Revised: 0419

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION

Container carton: 14's pack

containercarton

Blister Carton: 14's pack

blistercarton

OMEPRAZOLE 
omeprazole tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43598-286
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20 mg
Inactive Ingredients
Ingredient NameStrength
AMMONIA (UNII: 5138Q19F1X)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S) (UNII: 6N003M473W)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MONOETHANOLAMINE (UNII: 5KV86114PT)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
Polyethylene Glycol 3350 (UNII: G2M7P15E5P)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SODIUM STEARATE (UNII: QU7E2XA9TG)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
SHELLAC (UNII: 46N107B71O)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
ColorBROWN (brownish pink) Scoreno score
ShapeCAPSULESize12mm
FlavorImprint Code O20
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43598-286-5214 in 1 BOTTLE; Type 0: Not a Combination Product11/06/2018
2NDC:43598-286-272 in 1 CARTON11/06/2018
2NDC:43598-286-5214 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:43598-286-333 in 1 CARTON11/06/2018
3NDC:43598-286-5214 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:43598-286-741 in 1 CARTON11/06/2018
414 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:43598-286-252 in 1 CARTON11/06/2018
514 in 1 BLISTER PACK; Type 0: Not a Combination Product
6NDC:43598-286-373 in 1 CARTON11/06/2018
614 in 1 BLISTER PACK; Type 0: Not a Combination Product
7NDC:43598-286-322 in 1 CARTON11/06/2018
7NDC:43598-286-707 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20774011/06/2018
Labeler - Dr. Reddys Laboratories Inc (802315887)
Establishment
NameAddressID/FEIBusiness Operations
Dr.Reddy's Laboratories Limited (SEZ UNIT)860037244analysis(43598-286) , manufacture(43598-286)

Revised: 4/2019
Document Id: 375091c7-86fe-00dd-8dd8-7da0c6c42f07
Set id: 4b3b389d-a151-d851-cb05-64eb49979e5e
Version: 5
Effective Time: 20190430
 
Dr. Reddys Laboratories Inc