OMEPRAZOLE- omeprazole tablet, delayed release 
INNOVUS PHARMACEUTICALS, INC.

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Drug Facts

Active ingredient(in each tablet)

Omeprazole USP 20 mg

Purpose

Acid reducer

Keep Out of Reach of Children

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.

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

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.

Questionsor Comments?

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

Package/Label Principal Display Panel

NDC 57483-840-42

Compare To Prilosec OTC®

Treats FREQUENT Heartburn!

OmepraCareDR

Omeprazole

Delayed-release Tablets 20 mg

Acid Reducer

SWALLOW-DO NOT CHEW

24HR

42 TABLETS

Three 14-DAY courses of treatment

May take 1 to 4 days for full effect

spl-innovus-omeprazole-tablets
OMEPRAZOLE 
omeprazole tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57483-840
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:57483-840-423 in 1 CARTON08/10/2020
1NDC:57483-840-0114 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20789108/10/2020
Labeler - INNOVUS PHARMACEUTICALS, INC. (962507187)
Establishment
NameAddressID/FEIBusiness Operations
Sun Pharmaceutical Industries Limited650445203MANUFACTURE(57483-840)

Revised: 8/2020
Document Id: 7535a309-1a67-4f50-911b-7cf570322931
Set id: 7535a309-1a67-4f50-911b-7cf570322931
Version: 1
Effective Time: 20200810
 
INNOVUS PHARMACEUTICALS, INC.