OMEPRAZOLE - omeprazole tablet, delayed release 
Sun Pharmaceutical Industries, Inc.

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Omeprazole Delayed-release Tablets, 20 mg

Active ingredient(in each tablet)

Omeprazole USP 20 mg

Purpose

Acid reducer

Use

Warnings

Allergy alert: Do not use if you are allergic to omeprazole

Do not use

if you have:

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

Ask a docotor befor use if you have



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



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)

Directions


14-Day Course of Treatment

Repeated 14-Day Courses (if needed)

Other information

Inactive ingredients

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, titanium dioxide and triethyl citrate.

The imprinting ink contains ammonium hydroxide, black iron oxide, n-butyl alcohol, propylene glycol and shellac.

Questions or Comments?


Call toll free 1-800-818-4555 weekdays.

Tips of Managing Heartburn

Patient Package Insert

Omeprazole Delayed-Release Tablets, 20 mg

Acid Reducer

Please read all of this package insert before taking omeprazole delayed-release tablets 20 mg.  Save this to read, as you need.

How Omeprazole Delayed-Release Tablets 20 mg Work For Your Frequent Heartburn

Omeprazole delayed-release tablets 20 mg work differently from other heartburn products, such as antacids and other acid reducers. Omeprazole delayed-release tablets 20 mg stop acid production at the source - the acid pump that produces stomach acid.  Omeprazole delayed-release tablets 20 mg are to be used once-a-day (every 24 hours), every day for 14 days. 

What to Expect When Using Omeprazole Delayed-Release Tablets 20 mg 

Omeprazole delayed-release tablets 20 mg are different type of medicine from antacids and other acid reducers. Omeprazole delayed-release tablets 20 mg may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours.  Make sure you take the entire 14 days of dosing to treat your frequent heartburn. 

Who Should Take Omeprazole Delayed-Release Tablets 20 mg 

This product is for adults (18 years and older) with frequent heartburn - when you have heartburn 2 or more days a week.

How to Take Omeprazole Delayed-Release Tablets 20 mg  

14-Day Course of Treatment 

It is important not to chew or crush these tablets, or crush the tablets in food. This decreases how well omeprazole delayed-release tablets 20 mg work. 


When to Take Omeprazole Delayed-Release Tablets 20 mg Again 

You may repeat a 14-day course of therapy every 4 months.

When to Talk to Your Doctor 

Do not take for more than 14 days or more often than every 4 months unless directed by a doctor. 


Warnings and When to Ask Your Doctor 


Allergy alert:
  Do not use if you are allergic to omeprazole 


Do not use if you have:

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

Ask a doctor before use if you have:

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:

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)


Tips for Managing Heartburn

How are Omeprazole Delayed-Release Tablets 20 mg Sold

Omeprazole delayed-release tablets 20 mg are available in 14 tablet, 28 tablet and 42 tablet sizes. These sizes contain one, two and three 14-day courses of treatment, respectively. Do not use for more than 14 days in a row unless directed by your doctor. For the 28 count (two 14-day courses) and 42 count (three 14-day courses), you may repeat a 14-day course every 4 months.

For Questions or Comments About Omeprazole Delayed-Release Tablets 20 mg.

Call toll free 1-800-818-4555 weekdays.

Distributed by:

Sun Pharmaceutical Industries, Inc.

Cranbury, NJ 08512

Manufactured by:

Sun Pharmaceutical Industries Limited

Survey No. 259/15,

Dadra-396 191, (U.T. of D & NH), India.

PGPI0356

ISS. 04/2019

Principal Display Panel - Foil

62756-377-40
Omeprazole Delayed-release Tablet
20 mg
Acid reducer
PUSH THROUGH
Mfg. by: Sun Pharmaceutical Ind Ltd., India.
Dist. by: Sun Pharmaceutical Ind Inc., NJ 08512
PGPF0520


spl-omeprazole-foil

Principal Display Panel - Blister Carton

NDC 62756-377-96
Compare to Prilosec OTC ® *
Treats Frequent Heartburn! (24 HR)


Compare to Prilosec OTC ® *
Omeprazole Delayed-release Tablets
20 mg

Acid Reducer

SWALLOW - DO NOT CHEW
28 (2 x 14) Unit-Dose Tablets
TWO 14-DAY COURSES OF TREATMENT
May take 1 to 4 days for full effect

spl-omeprazole-carton-2

Principal Display Panel - Label


NDC 62756-377-21
TreatsFrequentHeartburn! (24 HR)
Omeprazole Delayed-release Tablets
20 mg
Acid Reducer
14 Tablets
ONE 14-DAY COURSE OF TREATMENT
May take 1 to 4 days for full effect
spl-omeprazole-label

Principal Display Panel - Bottle Carton


NDC 62756-377-11
Compare to Prilosec OTC ® *
Treats Frequent Heartburn(24 HR)
Omeprazole Delayed-release Tablets
20 mg
Acid Reducer
SWALLOW - DO NOT CHEW
28 Tablets
TWO 14-DAY COURSES OF TREATMENT
May take 1 to 4 days for full effect
spl-omeprazole-carton-28-tab

OMEPRAZOLE 
omeprazole tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62756-377
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MM2/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
ColorBROWN (brownish pink) Scoreno score
ShapeOVAL (biconvex) Size12mm
FlavorImprint Code 20
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62756-377-211 in 1 CARTON01/01/2019
114 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:62756-377-112 in 1 CARTON01/01/2019
214 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:62756-377-123 in 1 CARTON01/01/2019
314 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:62756-377-701 in 1 CARTON01/01/2019
414 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:62756-377-962 in 1 CARTON01/01/2019
514 in 1 BLISTER PACK; Type 0: Not a Combination Product
6NDC:62756-377-793 in 1 CARTON01/01/2019
614 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20789101/01/2019
Labeler - Sun Pharmaceutical Industries, Inc. (146974886)
Establishment
NameAddressID/FEIBusiness Operations
Sun Pharmaceutical Industries Limited650445203ANALYSIS(62756-377) , MANUFACTURE(62756-377)

Revised: 4/2019
Document Id: cd664883-a4cc-4ff4-b388-3e525b0e64b9
Set id: 51c3ef34-b7c1-419e-a784-ae82540c7a22
Version: 3
Effective Time: 20190429
 
Sun Pharmaceutical Industries, Inc.