OMEPRAZOLE- omeprazole tablet, delayed release

United States - English - NLM (National Library of Medicine)

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Active ingredient:
OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9)
Available from:
Thirty Madison Inc
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Acid Reducer • 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
Authorization status:
Abbreviated New Drug Application
Authorization number:
71713-201-01, 71713-201-03

OMEPRAZOLE- omeprazole tablet, delayed release

Thirty Madison Inc

----------

Omeprazole Delayed Release Tablets

Active Ingredient (in each tablet)

Omeprazole USP, 20mg

Purpos e

Acid Reducer

Us e

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

OMEPRAZOLE

omeprazole tablet, delayed release

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:71713-20 1

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O MEPRAZO LE (UNII: KG6 0 48 4QX9 ) (OMEPRAZOLE - UNII:KG6 0 48 4QX9 )

OMEPRAZOLE

20 mg

Inactive Ingredients

Ingredient Name

Stre ng th

AMMO NIA (UNII: 5138 Q19 F1X)

CARNAUBA WAX (UNII: R12CBM0 EIZ)

HYPRO MELLO SE ACETATE SUCCINATE 0 6 0 8 12 2 4 ( 3 MM2 /S) (UNII: 6 N0 0 3M473W)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

MO NO ETHANO LAMINE (UNII: 5KV8 6 114PT)

BUTYL ALCO HO L (UNII: 8 PJ6 1P6 TS3)

Po lyethylene Glyco l 3 3 50 (UNII: G2M7P15E5P)

PO LYVINYL ALCO HO L (UNII: 532B59 J9 9 0 )

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

Thirty Madison Inc

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

SO DIUM STEARATE (UNII: QU7E2XA9 TG)

SO DIUM STARCH GLYCO LATE TYPE A PO TATO (UNII: 58 56 J3G2A2)

SHELLAC (UNII: 46 N10 7B71O)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

SO DIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

TRIETHYL CITRATE (UNII: 8 Z9 6 QXD6 UM)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

Product Characteristics

Color

BROWN (bro wnish pink)

S core

no sco re

S hap e

CAPSULE

S iz e

12mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:71713-20 1-0 1

1 in 1 CARTON

0 5/31/20 19

1

14 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:71713-20 1-0 3

3 in 1 CARTON

0 5/31/20 19

2

14 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 7740

0 5/31/20 19

Labeler -

T hirty Madison Inc (080774087)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Dr.Reddy's Labo rato ries Limited (SEZ UNIT)

8 6 0 0 37244

analysis(71713-20 1) , manufacture(71713-20 1)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Reed Lane Inc

0 0 18 19 8 79

re pa c k(71713-20 1)

Revised: 3/2019

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