DailyMed - OMEPRAZOLE tablet, delayed release

NDC Code(s): 83324-141-14, 83324-141-42
Packager: Chain Drug Marketing Association INC

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

Drug Label Information

Updated January 17, 2025

If you are a consumer or patient please visit this version.

Download DRUG LABEL INFO: PDF XML
Official Label (Printer Friendly)

View All Sections

Active ingredient(s)
Omeprazole USP, 20 mg

Omeprazole USP, 20 mg
Close
Purpose
Acid reducer

Acid reducer
Close
Use(s)
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
Close
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 ...
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 lightheadednes
- 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 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)

Close
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 ...
- 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.
Close
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
Close
Inactive ingredients
ammonia solution, ammonium hydroxide, carnauba wax, hypromellose, hypromellose acetate succinate, iron oxide black, lactose monohydrate, monoethanolamine, n-butyl alcohol, polyethylene glycol ...

ammonia solution, ammonium hydroxide, carnauba wax, hypromellose, hypromellose acetate succinate, iron oxide black, lactose monohydrate, monoethanolamine, n-butyl alcohol, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, red iron oxide, shellac glaze, sodium lauryl sulphate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, talc, titanium dioxide, triethyl citrate, yellow iron oxide
Close
Questions or comments?
call 1-888-375-3784 - Distributed by: CDMA, Inc. Novi, MI 48375 - www.qualitychoice.com - Questions: 800-935-2362 - Made in India

call 1-888-375-3784

Distributed by:

CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Made in India

Close
Principal Display Panel
14count Container Label: 14count Carton Label:

14count Container Label:

14count Carton Label:

Close

INGREDIENTS AND APPEARANCE

Product Information

OMEPRAZOLE omeprazole tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83324-141
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
AMMONIA (UNII: 5138Q19F1X)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S) (UNII: 6N003M473W)
HYPROMELLOSES (UNII: 3NXW29V3WO)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MONOETHANOLAMINE (UNII: 5KV86114PT)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
Polyethylene Glycol 3350 (UNII: G2M7P15E5P)
POLYVINYL ALCOHOL (UNII: 532B59J990)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SODIUM STEARATE (UNII: QU7E2XA9TG)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
SHELLAC (UNII: 46N107B71O)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Product Characteristics
Color	BROWN (brownish pink)	Score	no score
Shape	CAPSULE	Size	12mm
Flavor		Imprint Code	O20
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:83324-141-42	3 in 1 CARTON	04/01/2025
1		14 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:83324-141-14	1 in 1 CARTON	04/01/2025
2		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	ANDA207740	04/01/2025

Labeler - Chain Drug Marketing Association INC (011920774)

View All Sections

Label: OMEPRAZOLE tablet, delayed release

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use if you have:

Ask a doctor before use if you have:

Ask a doctor or pharmacist before use if you are

Stop use and ask doctor if:

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

	NDC
1	83324-141-14
2	83324-141-42

Label: OMEPRAZOLE tablet, delayed release

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use if you have:

Ask a doctor before use if you have:

Ask a doctor or pharmacist before use if you are

Stop use and ask doctor if:

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

OMEPRAZOLE tablet, delayed release

Number of versions: 1

OMEPRAZOLE tablet, delayed release

OMEPRAZOLE tablet, delayed release

To receive this label RSS feed

To receive all DailyMed Updates for the last seven days

What will I get with the DailyMed RSS feed?

How to discontinue the RSS feed

Why is DailyMed no longer displaying pill images on the Search Results and Drug Info pages?

OMEPRAZOLE tablet, delayed release

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