OMEPRAZOLE - omeprazole tablet, delayed release 
Strategic Sourcing Services

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Omeprazole Delayed-release Tablets, 20 mg

Drug Facts

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 833-358-6431 Monday to Friday 9:00am to 7:00pm EST

Tips of Managing Heartburn

Distributed by McKesson Corp.,
via Strategic Sourcing Services LLC,
Memphis, TN 38141

PRINCIPAL DISPLAY PANEL - 14 Tablet Blister Pack Carton

sunmark®

COMPARE TO PRILOSEC OTC®

NDC 70677-0148-1

omeprazole

Delayed-release Tablets

20 mg / Acid Reducer

SWALLOW-DO NOT CHEW

Treats FREQUENT Heartburn!

24 HR

14 TABLETS

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

PRINCIPAL DISPLAY PANEL - 14 Tablet Blister Pack Carton
OMEPRAZOLE 
omeprazole tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70677-0148
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:70677-0148-11 in 1 CARTON01/01/2019
114 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 - Strategic Sourcing Services (116956644)
Establishment
NameAddressID/FEIBusiness Operations
Sun Pharmaceutical Industries Limited650445203MANUFACTURE(70677-0148)

Revised: 5/2022
Document Id: b4a9538c-049e-45d3-8b28-581c68a36ed6
Set id: dfa91081-3917-4dfc-9789-76800f57bb31
Version: 1
Effective Time: 20220511
 
Strategic Sourcing Services