OMEPRAZOLE- omeprazole tablet, delayed release 
BluePoint Laboratories

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Omeprazole Delayed Release Tablets

Active ingredient(s)

Omeprazole  USP, 20 mg

Purpose

Acid reducer

Use(s)

  • 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:

  • skin reddening
  • blisters
  • 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 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

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

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 to 25°C (68 to 77° F) and protect from moisture

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

*This product is not manufactured or distributed by Procter & Gamble, distributor of Prilosec OTC®. Prilosec OTC® is a registered trademark of AstraZeneca AB.

Manufactured for:

Dr. Reddy’s Laboratories, Inc.

Princeton, NJ 08540

For BluePoint Laboratories

Made in India

Revised:12/22

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION

Omeprazole Delayed-Release Tablets 20mg 14ct Carton

Omeprazole Delayed-Release Tablets 20mg 14ct Label

OMEPRAZOLE 
omeprazole tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68001-441
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)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
Colorbrown (brownish pink) Scoreno score
ShapeCAPSULESize12mm
FlavorImprint Code O20
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68001-441-5514 in 1 BOTTLE; Type 0: Not a Combination Product06/19/2020
2NDC:68001-441-981 in 1 CARTON06/19/2020
214 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:68001-441-392 in 1 CARTON06/19/2020
314 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:68001-441-403 in 1 CARTON06/19/2020
414 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20774006/19/2020
Labeler - BluePoint Laboratories (985523874)
Establishment
NameAddressID/FEIBusiness Operations
Dr.Reddy's Laboratories Limited (SEZ UNIT)860037244analysis(68001-441) , manufacture(68001-441)

Revised: 5/2023
 
BluePoint Laboratories