OTC Medication Information: Omeprazole

OMEPRAZOLE- omeprazole magnesium tablet, delayed release
P & L Development, LLC

ACTIVE INGREDIENT

(in each tablet)

Omeprazole delayed-release tablet 20 mg

(equivalent to 20.6 mg omeprazole magnesium)

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 a prescription drug.

Acid reducers may interact with certain 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.

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 everyday 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

acetyl tributyl citrate, colloidal silicon dioxide, corn starch, croscarmellose sodium, hydroxypropyl cellulose, hypromellose 2910, magnesium stearate, methacrylic acid copolymer type C, microcrystalline cellulose, polyethylene glycol 400, polyethylene glycol 3350, polyethylene glycol 8000, polyvinyl alcohol, red iron oxide, sucrose, talc, titanium dioxide, triethyl citrate

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Prilosec OTC®*

Omeprazole Delayed-Release Tablets 20 mg

ACID REDUCER

Treats FREQUENT Heartburn 24 Hr

One-14-Day Course of Treatment

14 Tablets

Omeprazole
(click image for full-size original)

Omeprazole Tablets

PACKAGE LABEL, PRINCIPAL DISPLAY PANEL

C ompare to the active ingredient in Prilosec OTC® *

Omeprazole Delayed-Release Tablets 20 mg

ACID REDUCER

SWALLOW — DO NOT CHEW

Treats FREQUENT Heartburn 24 HR

14 Tablets

One-14-Day Course of Treatment

Coated with Wildberry Flavor

Omeprazole
(click image for full-size original)

Ompeprazole Wildberry Tablets

OMEPRAZOLE
omeprazole magnesium tablet, delayed release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59726-297
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEPRAZOLE MAGNESIUM (OMEPRAZOLE) OMEPRAZOLE 20.6 mg
Inactive Ingredients
Ingredient Name Strength
ACETYLTRIBUTYL CITRATE
SILICON DIOXIDE
STARCH, CORN
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSE 2910 (15 MPA.S)
MAGNESIUM STEARATE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 400
POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 8000
POLYVINYL ALCOHOL, UNSPECIFIED
FERRIC OXIDE RED
SUCROSE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color RED Score no score
Shape OVAL (capsule-shaped) Size 13mm
Flavor Imprint Code OM;20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59726-297-14 1 BOTTLE in 1 CARTON contains a BOTTLE
1 14 TABLET, DELAYED RELEASE in 1 BOTTLE This package is contained within the CARTON (59726-297-14)
2 NDC:59726-297-28 2 BOTTLE in 1 CARTON contains a BOTTLE
2 14 TABLET, DELAYED RELEASE in 1 BOTTLE This package is contained within the CARTON (59726-297-28)
3 NDC:59726-297-42 3 BOTTLE in 1 CARTON contains a BOTTLE
3 14 TABLET, DELAYED RELEASE in 1 BOTTLE This package is contained within the CARTON (59726-297-42)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206582 06/02/2020
OMEPRAZOLE
omeprazole magnesium tablet, delayed release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59726-737
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEPRAZOLE MAGNESIUM (OMEPRAZOLE) OMEPRAZOLE 20.6 mg
Inactive Ingredients
Ingredient Name Strength
ACETYLTRIBUTYL CITRATE
SILICON DIOXIDE
STARCH, CORN
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSE 2910 (15 MPA.S)
MAGNESIUM STEARATE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
POLYETHYLENE GLYCOL 400
POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 8000
POLYVINYL ALCOHOL, UNSPECIFIED
SUCROSE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
DEXTROSE
FD&C BLUE NO. 2
FD&C RED NO. 40
PROPYLENE GLYCOL
TRIACETIN
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color PURPLE Score no score
Shape OVAL Size 13mm
Flavor BERRY Imprint Code OM;20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59726-737-14 1 BOTTLE in 1 CARTON contains a BOTTLE
1 14 TABLET, DELAYED RELEASE in 1 BOTTLE This package is contained within the CARTON (59726-737-14)
2 NDC:59726-737-28 2 BOTTLE in 1 CARTON contains a BOTTLE
2 14 TABLET, DELAYED RELEASE in 1 BOTTLE This package is contained within the CARTON (59726-737-28)
3 NDC:59726-737-42 3 BOTTLE in 1 CARTON contains a BOTTLE
3 14 TABLET, DELAYED RELEASE in 1 BOTTLE This package is contained within the CARTON (59726-737-42)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206582 06/02/2020
Labeler — P & L Development, LLC (800014821)

Revised: 10/2019 P & L Development, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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