OMEPRAZOLE - omeprazole tablet, delayed release 
Camber Consumer Care Inc

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Omeprazole Delayed-Release Tablets, 20 mg/acid reducer

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.
• Omeprazole may cause severe skin reactions. Symptoms may include:
   • skin reddening • blisters • rash
If an allergy 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.

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 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


colloidal silicon dioxide, crospovidone, glyceryl monostearate, hypromellose, hydroxypropyl cellulose, iron oxide red, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, silicified microcrystalline cellulose, sodium hydroxide, sodium lauryl sulphate, starlac (contains lactose monohydrate and corn starch), sugar spheres (contains sucrose and corn starch), talc, titanium dioxide, triethyl citrate.

Questions?

1-888-588-1418

PRINCIPAL DISPLAY PANEL

 

NDC 69230-318-35

See Current Drug Facts

Compare to Prilosec OTC ®*

Omeprazole
Delayed-Release Tablets
20 mg

Acid Reducer

Treats FREQUENT Heartburn!
Occuring 2 Or More Days A Week

24 HR

One 14-day course of treatment
May take 1 to 4 days for full effect

14 TABLETS

omeprazoledelayedreleasetablets14countcontainercarton
OMEPRAZOLE  
omeprazole tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69230-318
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSPOVIDONE (UNII: 68401960MK)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
SUCROSE (UNII: C151H8M554)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorpinkScoreno score
ShapeOVALSize14mm
FlavorImprint Code H;O9
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69230-318-351 in 1 CARTON03/25/2020
114 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:69230-318-362 in 1 CARTON03/25/2020
214 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:69230-318-373 in 1 CARTON03/25/2020
314 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:69230-318-321 in 1 CARTON03/25/2020
414 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:69230-318-332 in 1 CARTON03/25/2020
514 in 1 BLISTER PACK; Type 0: Not a Combination Product
6NDC:69230-318-343 in 1 CARTON03/25/2020
614 in 1 BLISTER PACK; Type 0: Not a Combination Product
7NDC:69230-318-05500 in 1 BOTTLE; Type 0: Not a Combination Product10/29/2020
8NDC:69230-318-101000 in 1 BOTTLE; Type 0: Not a Combination Product10/29/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21173203/25/2020
Labeler - Camber Consumer Care Inc (079539968)
Establishment
NameAddressID/FEIBusiness Operations
Hetero Labs Limited Unit III676162024manufacture(69230-318)

Revised: 11/2022
Document Id: ee873df8-2b35-9bc7-e053-2a95a90a0f83
Set id: 9c856d3a-e38f-4006-a43a-ec1a9fa0f057
Version: 5
Effective Time: 20221128
 
Camber Consumer Care Inc