Acid Reducer: Package Insert and Label Information

ACID REDUCER — omeprazole magnesium tablet, delayed release
KROGER COMPANY

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.
• 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 way.

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 (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 and ethyl acrylate 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 1-800-632-6900

DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202
MADE IN INDIA

Code: TS/DRUGS/22/2009

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

COMPARE TO the active ingredient in PRILOSE OTC®*
*See side panel
SEE CURRENT DRUG FACTS NDC 30142-077-05
Kroger
Omeprazole
Delayed-Release
Tablets 20 mg
ACID REDUCER
Treats
Frequent
Heartburn
24HR
14 TABLETS
ACTUAL
SIZE
One 14-Day Course of Treatment May Take 1 to 4 Days for Full Effect

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 20 mg (14 Tablet Carton Bottle)
(click image for full-size original)
ACID REDUCER omeprazole tablet, delayed release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-077
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEPRAZOLE MAGNESIUM (OMEPRAZOLE) OMEPRAZOLE 20 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE (35 .MU.M)
GLYCERYL MONOSTEARATE
HYDROXYPROPYL CELLULOSE (90000 WAMW)
HYPROMELLOSE 2910 (5 MPA.S)
MAGNESIUM STEARATE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 4000
POLYSORBATE 80
FERRIC OXIDE RED
SILICON DIOXIDE
SODIUM HYDROXIDE
SODIUM STEARYL FUMARATE
DEXTROSE, UNSPECIFIED FORM
STARCH, CORN
SUCROSE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
FERRIC OXIDE YELLOW
HYDROXYPROPYL CELLULOSE (45000 WAMW)
HYPROMELLOSE 2910 (6 MPA.S)
Product Characteristics
Color PINK Score no score
Shape RECTANGLE (Oblong) Size 14mm
Flavor Imprint Code Z;69
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:30142-077-01 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (30142-077-01)
2 NDC:30142-077-05 1 BOTTLE in 1 CARTON contains a BOTTLE
2 14 TABLET, DELAYED RELEASE in 1 BOTTLE This package is contained within the CARTON (30142-077-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206877 03/13/2023
Labeler — KROGER COMPANY (006999528)
Registrant — Aurohealth LLC (078728447)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650381903 ANALYSIS (30142-077), MANUFACTURE (30142-077)

Revised: 03/2023 KROGER COMPANY

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