OMEPRAZOLE- omeprazole capsule, delayed release 
AMERISOURCE BERGEN

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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

Uses

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 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.

Other information

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 1800-406-7984.

Distributed By:

AmerisourceBergen

1 West First Avenue

Conshohocken, PA 19428

Package/Label Principal Display Panel

†Compare To Prilosec OTC®

active ingredient

NDC 46122-686-03

2x14 COUNT BOTTLE INSIDE

Treats FREQUENT Heartburn!

24

HR

Omeprazole

Delayed-release Capsules

20 mg* / Acid Reducer

ohm®

28 CAPSULES

Two 14-day courses of treatment

May take 1 to 4 days for full effect

spl-gnp-omeprazole-caps
OMEPRAZOLE 
omeprazole capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-686
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:46122-686-032 in 1 BLISTER PACK03/31/2021
1NDC:46122-686-7414 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21059303/31/2021
Labeler - AMERISOURCE BERGEN (007914906)
Registrant - AMERISOURCE BERGEN (007914906)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.184769029MANUFACTURE(46122-686)

Revised: 3/2021
Document Id: 47dce86f-d184-44cf-8ee3-18dad7f401b8
Set id: 47dce86f-d184-44cf-8ee3-18dad7f401b8
Version: 1
Effective Time: 20210331
 
AMERISOURCE BERGEN