Drug Labeling and Warnings

Drug Details

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ACID REDUCER - omeprazole tablet, delayed release 
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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

Drug Facts

Active ingredient (in each tablet)

Omeprazole delayed-release tablet 20 mg (equivalent to 20.6 mg omeprazole magnesium USP)

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 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 (1-800-222-1222)  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 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 20º to 25ºC (68º to 77º F) and protect from moisture

Inactive ingredients

crospovidone, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer dispersion, microcrystalline cellulose, polyethylene glycol, polysorbate 80, red iron oxide, silicified microcrystalline cellulose, sodium hydroxide, sodium stearyl fumarate, sugar spheres [which contains liquid glucose, starch (maize) and sucrose], talc, titanium dioxide,  triethyl citrate and yellow iron oxide.

Questions?

Call 1-855-274-4122

PROUDLY DISTRIBUTED BY:
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5000 KANSAS AVE. KANSAS CITY, KS 66106
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Code TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablet Bottle)

NDC: 63941-006-05
Acid Reducer                                     Best
OMEPRAZOLE                                 Choice®
DELAYED-RELEASE TABLETS 20 mg
24 HR                                                                                    14 TABLETS
Treats Frequent Heartburn                    One 14-day course of treatment
                                                                 May take 1 to 4 days for full effect

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablet Bottle)
 

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg Container Carton Label

NDC: 63941-006-05
                                   Best
                                 Choice®
COMPARE TO THE ACTIVE
INGREDIENT IN PRILOSEC OTC®*
Acid Reducer
OMEPRAZOLE
DELAYED-RELEASE
TABLETS 20 mg
24 HR
Treats FREQUENTS Heartburn
14 TABLETS
One 14-day course of treatment
May take 1 to 4 days for full effect
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg Blister Carton Label

ACID REDUCER 
omeprazole tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63941-006
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEPRAZOLE MAGNESIUM (UNII: 426QFE7XLK) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE (35 .MU.M) (UNII: 40UAA97IT9)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F)  
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
STARCH, CORN (UNII: O8232NY3SJ)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYDROXYPROPYL CELLULOSE (45000 WAMW) (UNII: 8VAB711C5E)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
Product Characteristics
ColorPINKScoreno score
ShapeRECTANGLE (Oblong) Size14mm
FlavorImprint Code Z;69
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63941-006-051 in 1 CARTON06/06/2018
114 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC: 63941-006-623 in 1 CARTON06/06/2018
214 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20687706/06/2018
Labeler - Best Choice (868703513)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(63941-006) , MANUFACTURE(63941-006)

Revised: 12/2018
 
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