OMEPRAZOLE tablet, delayed release

Omeprazole by

Drug Labeling and Warnings

Omeprazole by is a Otc medication manufactured, distributed, or labeled by Thirty Madison Inc, Dr.Reddy's Laboratories Limited (SEZ UNIT), Reed Lane Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each tablet)

Omeprazole USP, 20mg

Purpose

Acid Reducer

Use

Treats frequent heartburn (occurs2 or more days a week)

not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

WARNINGS SECTION

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 beofre using if you are

taking:

warfarin, clopidogrel or cilostazol (blood thinning medications)

prescription antifungal or anti-yeast medicines

diazepam (anxiety medicine)

digoxin (heart medicine)

tacrolimus or mycophenolate mofetil (immune system medicines)

prescription antiretrovirals (medicines for HIV infection)

methotrexate (arthritis medicine)

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 treatement 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 (1800-222-1222)

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 relief of symptoms within 24 hours

14 day course of treatment

swallow 1 tablet with a glass of water befre 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 days 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

ammonia solution, ammonium hydroxide, carnauba wax, hypromellose acetate succinate, hypromellose, iron oxide black, lactose monohydrate, monoethanolamine, n-butyl alcohol, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, red iron oxide, sodium stearate, sodium starch glycolate, shellac glaze, sodium lauryl sulphate, sodium stearyl fumarate, talc, titanim dioxide, triethyl citrate, yellow iron oxide

Questions or comments?

call 1-888-375-3784

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

Carton label

Bottle Label

INGREDIENTS AND APPEARANCE

OMEPRAZOLE 
omeprazole tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71713-201
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
AMMONIA (UNII: 5138Q19F1X)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S) (UNII: 6N003M473W)
HYPROMELLOSES (UNII: 3NXW29V3WO)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MONOETHANOLAMINE (UNII: 5KV86114PT)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
Polyethylene Glycol 3350 (UNII: G2M7P15E5P)
POLYVINYL ALCOHOL (UNII: 532B59J990)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SODIUM STEARATE (UNII: QU7E2XA9TG)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
SHELLAC (UNII: 46N107B71O)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Product Characteristics
Color	BROWN (brownish pink)	Score	no score
Shape	CAPSULE	Size	12mm
Flavor		Imprint Code	O20
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71713-201-01	1 in 1 CARTON	05/31/2019
1		14 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 71713-201-03	3 in 1 CARTON	05/31/2019
2		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	ANDA207740	05/31/2019

Labeler - Thirty Madison Inc (080774087)

Establishment
Name	Address	ID/FEI	Business Operations
Dr.Reddy's Laboratories Limited (SEZ UNIT)		860037244	analysis(71713-201) , manufacture(71713-201)

Establishment
Name	Address	ID/FEI	Business Operations
Reed Lane Inc		001819879	repack(71713-201)