omeprazole — v2

omeprazole

8 Views

Version

v2

Effective date

September 22, 2025

Original packager

Yes

Sections captured

16

Identifiers

Document ID
3f68d110-48d3-6617-e063-6394a90ad44f
Set ID
30ca370c-c38f-4ad3-e063-6294a90af87f
Application numbers
NDA022032
Product NDCs
59368-321
Package NDCs
59368-321-01, 59368-321-02, 59368-321-03
Original packager NDCs

Names & Manufacturers

Brand names
omeprazole
Generic names
OMEPRAZOLE
Manufacturer names
Sixarp, LLC
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
OMEPRAZOLE
Routes
ORAL
Pharmacologic class (PE)
Pharmacologic class (EPC)
Proton Pump Inhibitor [EPC]
Pharmacologic class (CS)
Mechanism of action
Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitors [MoA]

Other identifiers

NUI
N0000000147, N0000175525, N0000182140
RxCUI
402014
UNII
KG60484QX9
UPC

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient (in each tablet) Omeprazole 20 mg
Ask Doctor (1)

Sequence 1

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 Doctor Or Pharmacist (1)

Sequence 1

Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.
Do Not Use (1)

Sequence 1

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.
Dosage And Administration (1)

Sequence 1

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, crush, or suck tablets. Repeated 14-Day Courses (if needed) you may repeat a14-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.
Inactive Ingredient (1)

Sequence 1

Inactive ingredients benzyl alcohol, carmine, carnauba wax, FD&C blue #2/indigo carmine aluminum lake, flavor, hypromellose, hypromellose acetate succinate, lactose monohydrate, menthol, modified starch, monoethanolamine, polyethylene glycol 3350, sodium lauryl sulfate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, sucralose, talc, titanium dioxide, triacetin, triethyl citrate
Indications And Usage (1)

Sequence 1

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
Keep Out Of Reach Of Children (1)

Sequence 1

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).
Package Label Principal Display Panel (1)

Sequence 1

Package/Label Principal Display Panel TREATS FREQUENT HEARTBURN! Compare to Prilosec OTC ® OMEPRAZOLE Delayed Release Tablets, 20 mg ACID REDUCER ACTUAL SIZE 24HR WILDBERRY MINT COATED TABLET SWALLOW – DO NOT CHEW 28 TABLETS TWO 14-DAY COURSES OF TREATMENT MAY TAKE 1 TO 4 DAYS FOR FULL EFFECT carton omeprazole image-2
Pregnancy Or Breast Feeding (1)

Sequence 1

If pregnant or breast-feeding, ask a health professional before use.
Purpose (1)

Sequence 1

Purpose Acid reducer
Questions (1)

Sequence 1

Questions or comments? 1-800-719-9260
Spl Product Data Elements (1)

Sequence 1

omeprazole Omeprazole BENZYL ALCOHOL CARNAUBA WAX FD&C BLUE NO. 2 HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MENTHOL, UNSPECIFIED FORM MONOETHANOLAMINE POLYETHYLENE GLYCOL 3350 SODIUM LAURYL SULFATE SODIUM STEARATE SODIUM STEARYL FUMARATE SUCRALOSE TALC TITANIUM DIOXIDE TRIACETIN TRIETHYL CITRATE OMEPRAZOLE OMEPRAZOLE 20
Stop Use (1)

Sequence 1

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
Storage And Handling (1)

Sequence 1

Other information read the directions and warnings before use keep the carton. It contains important information. store at 20-25°C (68-77°F) and protect from moisture
Warnings (1)

Sequence 1

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 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).

OpenFDA raw payload

{'application_number': ['NDA022032'],
 'brand_name': ['omeprazole'],
 'generic_name': ['OMEPRAZOLE'],
 'is_original_packager': [True],
 'manufacturer_name': ['Sixarp, LLC'],
 'nui': ['N0000175525', 'N0000000147', 'N0000182140'],
 'package_ndc': ['59368-321-02', '59368-321-01', '59368-321-03'],
 'pharm_class_epc': ['Proton Pump Inhibitor [EPC]'],
 'pharm_class_moa': ['Proton Pump Inhibitors [MoA]',
                     'Cytochrome P450 2C19 Inhibitors [MoA]'],
 'product_ndc': ['59368-321'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['ORAL'],
 'rxcui': ['402014'],
 'spl_id': ['3f68d110-48d3-6617-e063-6394a90ad44f'],
 'spl_set_id': ['30ca370c-c38f-4ad3-e063-6294a90af87f'],
 'substance_name': ['OMEPRAZOLE'],
 'unii': ['KG60484QX9']}