OMEPRAZOLE tablet, delayed release

omeprazole by

Drug Labeling and Warnings

omeprazole by is a Otc medication manufactured, distributed, or labeled by INNOVUS PHARMACEUTICALS, INC., Sun Pharmaceutical Industries Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 more days 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 include:
  • skin reddening
  • blisters
  • rash

If an allergic 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 (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 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.

Safety Feature - Do not use if printed seal under cap is broken or missing.

Tips for Managing Heartburn

• Do not lie flat or bend over after eating
• Do not wear tight-fitting clothing around the stomach
• Do not eat before bedtime
• Raise the head of your bed
• Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol and certain fruits and vegetables
• Eat slowly and avoid big meals
• If overweight, lose weight
• Quit smoking

Distributed By:
Innovus Pharmaceuticals, Inc.
Englewood, CO 80112, USA

PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Carton

†Compare to Prilosec OTC®
NDC: 57483-840-42

Crcle™

Heartburn
Relief

OmepraCareDR™

Omeprazole
Delayed-release Tablets

20 mg / Acid Reducer

24
hour
Treats FREQUENT Heartburn!

SWALLOW – DO NOT CHEW

42 TABLETS

Three 14-Day courses of treatment
May take 1 to 4 days for full effect
TRIPLE PACK 3X14 count bottles inside

INGREDIENTS AND APPEARANCE

OMEPRAZOLE 
omeprazole tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57483-840
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
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MPA.S) (UNII: 36BGF0E889)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
2-AMINOETHANOL (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
Color	BROWN (brownish pink)	Score	no score
Shape	OVAL (biconvex)	Size	12mm
Flavor		Imprint Code	20
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57483-840-42	3 in 1 CARTON	08/10/2020
1	NDC: 57483-840-01	14 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA207891	08/10/2020

Labeler - INNOVUS PHARMACEUTICALS, INC. (962507187)

Establishment
Name	Address	ID/FEI	Business Operations
Sun Pharmaceutical Industries Limited		650445203	MANUFACTURE(57483-840)