OMEPRAZOLE tablet, delayed release

Omeprazole by

Drug Labeling and Warnings

Omeprazole by is a Otc medication manufactured, distributed, or labeled by CHAIN DRUG MARKETING ASSOCIATION, INC., Hetero Labs Limited Unit III. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Omeprazole delayed-release tablet, 20 mg
(equivalent to 20.6 mg omeprazole magnesium USP)

Purpose

Acid reducer

Use

 treats frequent heartburn (occurs 2 or moredays 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 allergy 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.

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 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

colloidal silicon dioxide, crospovidone, glyceryl monostearate, hypromellose, hydroxypropyl cellulose, iron oxide red, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, silicified microcrystalline cellulose, sodium hydroxide, sodium lauryl sulphate, starlac (contains lactose monohydrate and corn starch), sugar spheres (contains sucrose and corn starch), talc, titanium dioxide, triethyl citrate.

Questions?

1-888-375-3784

PRINCIPAL DISPLAY PANEL

 

NDC: 83324-011-42

See Current Drug Facts

Compare to Prilosec OTC ®*

Omeprazole
Delayed-Release Tablets
20 mg

Acid Reducer

Treats FREQUENTHeartburn!
Occuring 2 Or More Days A Week

24 HR

One 14-day course of treatment
May take 1 to 4 days for full effect

14TABLETS

 

INGREDIENTS AND APPEARANCE

OMEPRAZOLE 
omeprazole tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83324-011
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSPOVIDONE (UNII: 68401960MK)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TALC (UNII: 7SEV7J4R1U)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)
SUCROSE (UNII: C151H8M554)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	pink	Score	no score
Shape	OVAL	Size	14mm
Flavor		Imprint Code	H;O9
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83324-011-14	1 in 1 CARTON	05/10/2024
1		14 in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC: 83324-011-42	3 in 1 CARTON	05/10/2024
2		14 in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA211732	05/10/2024

Labeler - CHAIN DRUG MARKETING ASSOCIATION, INC. (011920774)

Establishment
Name	Address	ID/FEI	Business Operations
Hetero Labs Limited Unit III		676162024	manufacture(83324-011)