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

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Drug Facts

Active ingredient(in each capsule)

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

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.

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 (1-800-222-1222).

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 capsule with a glass of water before eating in the morning

■ take every day for 14 days

■ do not take more than 1 capsule a day

■ do not use for more than 14 days unless directed by your doctor

■ swallow whole. Do not chew or crush capsules.

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.

Otherinformation

read the directions and warnings before use

■ keep the carton. It contains important information.

■ Store at 20-25°C (68-77°F). [See USP controlled room temperature].

Protect from moisture

Inactive Ingredients

FD&C blue #1, FD&C red #40, ferrosoferric oxide, gelatin, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium stearate, methacrylic acid copolymer, mono and di glycerides, polyethylene glycol 6000, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sodium stearyl fumarate, sugar spheres (starch and sucrose), talc, titanium dioxide and triethyl citrate

Questions

Call toll-free Monday to Friday 8:30 am to 5 pm EST at 1-800-818-4555.

Package/Label Principal Display Panel

NDC 57483-740-42

Compare To the active ingredient of Prilosec OTC®

Treats FREQUENT Heartburn!

OmepraCareDR

Omeprazole

Delayed-release Capsules 20 mg*

Acid Reducer

Mini Cap 40% Smaller Capsule

24HR

42 CAPSULES

Three 14-DAY courses of treatment

May take 1 to 4 days for full effect

spl-innovus-carton
OMEPRAZOLE 
omeprazole capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57483-740
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEPRAZOLE MAGNESIUM (UNII: 426QFE7XLK) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20.6 mg
Inactive Ingredients
Ingredient NameStrength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
STARCH, CORN (UNII: O8232NY3SJ)  
SUCROSE (UNII: C151H8M554)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code RG49
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57483-740-423 in 1 CARTON08/06/2020
1NDC:57483-740-0114 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21059308/06/2020
Labeler - INNOVUS PHARMACEUTICALS, INC. (962507187)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.184769029MANUFACTURE(57483-740)

Revised: 8/2020
Document Id: ce5c9fdc-0c50-4315-8f11-e00c9810abd0
Set id: ce5c9fdc-0c50-4315-8f11-e00c9810abd0
Version: 1
Effective Time: 20200806
 
INNOVUS PHARMACEUTICALS, INC.