ACID REDUCER- omeprazole tablet, delayed release

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

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Active ingredient:
OMEPRAZOLE MAGNESIUM (UNII: 426QFE7XLK) (OMEPRAZOLE - UNII:KG60484QX9)
Available from:
7-Eleven
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 - 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. - 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 taking a prescription drug. Acid reducers may interact with certain prescription drugs. - 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
Authorization status:
Abbreviated New Drug Application
Authorization number:
10202-722-05

ACID REDUCER - omeprazole tablet, delayed release

7-Eleven

----------

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

Drug Facts

Active ingredient (in each tablet)

Omeprazole delayed-release tablet 20 mg (equivalent to 20.6 mg omeprazole magnesium USP)

Purpose

Acid reducer

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

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 (1-800-222-1222) right away.

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 20º to 25ºC (68º to 77º F) and protect from moisture

Inactive ingredients

crospovidone, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate,

methacrylic acid copolymer dispersion, microcrystalline cellulose, polyethylene glycol, polysorbate

80, red iron oxide, silicified microcrystalline cellulose, sodium hydroxide, sodium stearyl fumarate,

sugar spheres [which contains liquid glucose, starch (maize) and sucrose], talc, titanium dioxide,

triethyl citrate and yellow iron oxide.

Questions?

Call 1-855-274-4122

Distributed by:

7-ELEVEN, INC.

IRVING, TX 75063

www.7-ELEVEN.COM

Made in India

Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablet Bottle)

24/7 Life BY 7-Eleven

See Current Drug Facts

Omeprazole Delayed-Release Tablets 20 mg

ACID REDUCER

14 TABLETS

Treats Frequent Heartburn

Occuring 2 or More Days a Week

One 14-Day Course of Treatment

TM

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg Container Carton Label 14(1x14)

Tablets

24/7 BY 7-ELEVEN

See current Drug Facts

Omeprazole

Delayed-Release

Tablets 20 mg

ACID REDUCER 24 HR

Treats Frequent Heartburn!

compare to

PRILOSEC OTC®

active ingredient*

14

TABLETS

One 14-day course

of treatment

May take 1 to 4 days

for full effect

TM

ACID REDUCER

omeprazole tablet, delayed release

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:10 20 2-722

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O MEPRAZO LE MAGNESIUM (UNII: 426 QFE7XLK) (OMEPRAZOLE - UNII:KG6 0 48 4QX9 )

OMEPRAZOLE

20 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CRO SPO VIDO NE ( 12 MPA.S AT 5%) (UNII: 40 UAA9 7IT9 )

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

HYDRO XYPRO PYL CELLULO SE ( 9 0 0 0 0 WAMW) (UNII: UKE75GEA7F)

HYPRO MELLO SE 2 9 10 ( 5 MPA.S) (UNII: R75537T0 T4)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

METHACRYLIC ACID - ETHYL ACRYLATE CO PO LYMER ( 1:1) TYPE A (UNII: NX76 LV5T8 J)

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

PO LYETHYLENE GLYCO L 4 0 0 0 (UNII: 4R4HFI6 D9 5)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

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

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

SO DIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)

DEXTRO SE, UNSPECIFIED FO RM (UNII: IY9 XDZ35W2)

STARCH, CO RN (UNII: O8 232NY3SJ)

SUCRO SE (UNII: C151H8 M554)

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)

HYDRO XYPRO PYL CELLULO SE ( 4 50 0 0 WAMW) (UNII: 8 VAB711C5E)

HYPRO MELLO SE 2 9 10 ( 6 MPA.S) (UNII: 0 WZ8 WG20 P6 )

Product Characteristics

Color

PINK

S core

no sco re

S hap e

RECTANGLE (Oblo ng)

S iz e

14mm

Flavor

Imprint Code

Z;6 9

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:10 20 2-722-0 5

1 in 1 CARTON

0 6 /0 6 /20 18

1

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 6 8 77

0 6 /0 6 /20 18

Labeler -

7-Eleven (007347602)

7-Ele ve n

Registrant -

Aurohealth LLC (078728447)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Auro bindo Pharma Limited

6 50 38 19 0 3

ANALYSIS(10 20 2-722) , MANUFACTURE(10 20 2-722)

Revised: 10/2019

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