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Omeprazole ODT: Package Insert / Prescribing Info

Package insert / product label
Dosage form: tablet, orally disintegrating, delayed release
Drug class: Proton pump inhibitors

Medically reviewed by Drugs.com. Last updated on Apr 10, 2025.

Active ingredient (in each tablet)

Omeprazole 20 mg

Purpose

Acid reducer

Indications and Usage for Omeprazole ODT

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 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 right away (1-800-222-1222).

Omeprazole ODT Dosage and Administration

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
take 1 tablet before eating in the morning
do not crush or chew tablets
place the tablet on tongue; tablet disintegrates, with or without water. The tablets can also be swallowed whole with water.
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
do not take this medicine with alcohol
Repeated 14-Day Course (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 before use. Heartburn in children may sometimes be caused by a serious condition.

Storage and Handling

read the directions and warnings before use
keep the carton. It contains important information.
store at 20-25°C (68-77°F); keep product out of high heat and moisture
take the tablet immediately after opening individual blister. Do not store the tablet outside the blister pack for future use.

Inactive ingredients

amino methacrylate copolymer, ascorbic acid, cetyl alcohol, colloidal silicon dioxide, crospovidone, ferric oxide, flavor, hypromellose, hypromellose phthalate, maize maltodextrin, mannitol, microcrystalline cellulose, propylene glycol, silicon dioxide, sodium stearate, sodium stearyl fumarate, sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate

Questions or comments?

Package/Label Principal Display Panel

COMPARE TO PRILOSEC OTC® See side panel

Kroger®

OUR PHARMACIST RECOMMENDED

Omeprazole

Delayed Release Orally Disintegrating Tablets 20 mg

MELTech® Melts In Your Mouth

Treats FREQUENT Heartburn!

ACID REDUCER

24 HR

Dissolve Tabs

MELTS IN YOUR MOUTH

Dissolves without water

actual size

42 TABLETS

Strawberry Flavor

Three 14-Day Courses of Treatment

May Take 1 to 4 Days for Full Effect

kroger-omeprazole-strawberry-carton-image.jpg
OMEPRAZOLE
omeprazole tablet, orally disintegrating, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-394
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20 mg
Inactive Ingredients
Ingredient NameStrength
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
FERRIC OXIDE RED (UNII: 1K09F3G675)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MANNITOL (UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM STEARATE (UNII: QU7E2XA9TG)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
Product Characteristics
ColorRED (reddish) Scoreno score
ShapeROUNDSize9mm
FlavorSTRAWBERRYImprint Code20
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-394-7414 in 1 CARTON04/10/201809/01/2022
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:30142-394-553 in 1 CARTON04/10/2018
214 in 1 CARTON
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20940004/10/2018
Labeler - Kroger Company (006999528)

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