Skip to Content

← See all Omeprazole brands

Omeprazole by Reliable 1 Laboratories LLC

Medically reviewed on Oct 20, 2017

Dosage form: capsule
Ingredients: OMEPRAZOLE MAGNESIUM 20mg
Labeler: Reliable 1 Laboratories LLC
NDC Code: 69618-047

Omeprazole 20 mg

Drug Facts

Active ingredient (in each capsule)

*Omeprazole delayed-release capsules 20 mg (equivalent to 20.6 mg omeprazole magnesium)

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:

  • warfarin, clopidogrel or cilostazol (blood-thinning medicines)
  • 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 treatment every 4 months
  • you get diarrhea

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 prodcut 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 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 serious condition.

Other information
  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • store at 20-25ºC (68-77ºF) and protect from moisture

Inactive ingredients

black iron oxide, dibasic calcium phosphate, gelatin, glyceryl monostearate, hypromellose 3 cps, magnesium odixe, magnesium stearate, methacrylic acid copolymer dispersion, methacrylic acid copolymer Type B, microcrystalline cellulose, polysorbate 80, potassium hydroxide, propylene glycol, red iron odixe, shellac, silicon dioxide, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate

Questions?

call 1-888-375-3784

NDC 69618-047-42

Compare to the active ingredient in Prilosec OTC®** Treats Frequent Heartburn! Occurring 2 or More Days A Week

Omeprazole

Delayed-release Capsules

20 mg*

Acid Reducer

42 Capsules (Safety Sealed)

Three 14-Day Courses of Treatment

OMEPRAZOLE 
omeprazole capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69618-047
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEPRAZOLE MAGNESIUM (OMEPRAZOLE) OMEPRAZOLE20 mg
Inactive Ingredients
Ingredient NameStrength
TITANIUM DIOXIDE 
POTASSIUM HYDROXIDE 
TRIETHYL CITRATE 
PROPYLENE GLYCOL 
RAW SUGAR 
MAGNESIUM OXIDE 
MAGNESIUM STEARATE 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
GLYCERYL MONOSTEARATE 
CARRAGEENAN 
MICROCRYSTALLINE CELLULOSE 
FERRIC OXIDE RED 
SHELLAC 
SILICON DIOXIDE 
SODIUM LAURYL SULFATE 
TALC 
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A 
POLYSORBATE 80 
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2) 
HYPROMELLOSE 2208 (3 MPA.S) 
Product Characteristics
Colorpink (Half White, Half Pink) , white (Half White, Half Pink) Scoreno score
ShapeCAPSULESize22mm
FlavorImprint CodeOMP20
Contains    
Packaging
#Item CodePackage Description
1NDC:69618-047-423 BOTTLE, PLASTIC in 1 CARTON
1NDC:69618-047-1414 CAPSULE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07887808/16/2017
Labeler - Reliable 1 Laboratories LLC (079718111)

 
Reliable 1 Laboratories LLC

← See all Omeprazole brands

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide