DailyMed - OMEPRAZOLE tablet, delayed release

NDC Code(s): 51660-029-14, 51660-029-27, 51660-029-44
Packager: OHM LABORATORIES INC.

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 29, 2024

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SPL UNCLASSIFIED SECTION
Drug Facts

Drug Facts
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Active ingredient(in each tablet)
Omeprazole USP 20 mg

Omeprazole USP 20 mg
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Purpose
Acid reducer

Acid reducer
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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

•

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

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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 ...

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

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heartburn with lightheadedness, sweating or dizziness

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chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness

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frequent chest pain

These may be signs of a serious condition. See your doctor.

Ask a doctor before use if you have

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had heartburn over 3 months. This may be a sign of a more serious condition.

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frequent wheezing, particularly with heartburn

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unexplained weight loss

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nausea or vomiting

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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

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your heartburn continues or worsens

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you need to take this product for more than 14 days

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you need to take more than 1 course of treatment every 4 months

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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).

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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 ...

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for adults 18 years of age and older

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this product is to be used once a day (every 24 hours), every day for 14 days

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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

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swallow 1 tablet with a glass of water before eating in the morning

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take every day for 14 days

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do not take more than 1 tablet a day

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do not use for more than 14 days unless directed by your doctor

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swallow whole. Do not chew or crush tablets.

Repeated 14-Day Courses (if needed)

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you may repeat a 14-day course every 4 months

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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.

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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

•

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

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Inactive ingredients
anhydrous lactose, hypromellose, hypromellose acetate succinate, iron oxide red, iron oxide yellow, lactose monohydrate, methyl cellulose, monoethanolamine, propylene glycol, sodium lauryl ...

anhydrous lactose, hypromellose, hypromellose acetate succinate, iron oxide red, iron oxide yellow, lactose monohydrate, methyl cellulose, monoethanolamine, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, talc, triethyl citrate and titanium dioxide.

The imprinting ink contains ammonium hydroxide, black iron oxide, n-butyl alcohol, propylene glycol and shellac.
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Questions or Comments?
Call toll free 1-800-818-4555 weekdays.

Call toll free 1-800-818-4555 weekdays.
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SPL UNCLASSIFIED SECTION
Distributed by: Ohm Laboratories Inc. New Brunswick, NJ 08901 - Manufactured by: Sun Pharmaceutical Industries Limited - Survey No. 1012, Dadra-396 193, U.T. of D & NH and Daman & Diu, India.

Distributed by:
Ohm Laboratories Inc.
New Brunswick, NJ 08901

Manufactured by:
Sun Pharmaceutical Industries Limited
Survey No. 1012, Dadra-396 193,
U.T. of D & NH and Daman & Diu, India.
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PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Carton
†Compare To Prilosec OTC® NDC 51660-029-27 - Omeprazole - Delayed-release Tablets - 20 mg / Acid Reducer - SWALLOW- DO NOT CHEW - Treats FREQUENT Heartburn! 24 - HR - 28 TABLETS - Two 14-day courses of ...

†Compare To Prilosec OTC®
NDC 51660-029-27

Omeprazole
Delayed-release Tablets
20 mg / Acid Reducer

SWALLOW- DO NOT CHEW

Treats FREQUENT Heartburn!
24
HR

28 TABLETS
Two 14-day courses of treatment
May take 1 to 4 days for full effect

ohm®

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INGREDIENTS AND APPEARANCE

Product Information

OMEPRAZOLE omeprazole tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51660-029
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9)	OMEPRAZOLE	20 mg

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MPA.S) (UNII: 36BGF0E889)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MONOETHANOLAMINE (UNII: 5KV86114PT)
METHYLCELLULOSE (1500 MPA.S) (UNII: P0NTE48364)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
SODIUM STEARATE (UNII: QU7E2XA9TG)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
AMMONIA (UNII: 5138Q19F1X)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
SHELLAC (UNII: 46N107B71O)

Product Characteristics
Color	BROWN (brownish pink)	Score	no score
Shape	OVAL (biconvex)	Size	12mm
Flavor		Imprint Code	20
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51660-029-44	3 in 1 CARTON	06/01/2019
1		14 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:51660-029-14	1 in 1 CARTON	06/01/2019
2		14 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:51660-029-27	2 in 1 CARTON	06/01/2019
3		14 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA207891	06/01/2019

Labeler - OHM LABORATORIES INC. (184769029)

Name	Address	ID/FEI	Business Operations
Establishment
Sun Pharmaceutical Industries Limited		650445203	ANALYSIS(51660-029) , MANUFACTURE(51660-029)

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Published Date (What is this?)	Version	Files
Mar 4, 2024	8 (current)	download
Feb 22, 2024	7	download
Dec 30, 2022	6	download
Dec 19, 2022	5	download
Oct 27, 2022	4	download
Aug 17, 2020	3	download
Aug 28, 2019	2	download
Jun 3, 2019	1	download

	RxCUI	RxNorm NAME	RxTTY
1	402014	omeprazole 20 MG Delayed Release Oral Tablet	PSN
2	402014	omeprazole 20 MG Delayed Release Oral Tablet	SCD
3	402014	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Tablet	SY

Label: OMEPRAZOLE tablet, delayed release

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Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Allergy alert

Do not use if you have

Ask a doctor before use if you have

Stop use and ask a doctor if

Find additional resources

Safety

Related Resources

More Info on this Drug

	NDC
1	51660-029-14
2	51660-029-27
3	51660-029-44

Label: OMEPRAZOLE tablet, delayed release

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Allergy alert

Do not use if you have

Ask a doctor before use if you have

Stop use and ask a doctor if

Find additional resources

Safety

Related Resources

More Info on this Drug

OMEPRAZOLE tablet, delayed release

Number of versions: 8

OMEPRAZOLE tablet, delayed release

OMEPRAZOLE tablet, delayed release

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OMEPRAZOLE tablet, delayed release

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.