OMEPRAZOLE MAGNESIUM capsule, delayed release

Omeprazole Magnesium by

Drug Labeling and Warnings

Omeprazole Magnesium by is a Otc medication manufactured, distributed, or labeled by Kaiser Permanente. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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
• side effects occur. You may report side effects to FDA at 1-800-FDA-1088

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 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) and protect from moisture

Inactive ingredients

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

Questions?

call 1-800-FDA-1088 (1-800-332-1088)

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

Omeprazole Delayed-Release Capsules, 20 mg, 28-count - Carton Label

NDC: 0179-8104-28

KAISER PERMANENTE®

Omeprazole
Delayed-release capsules
20 mg*
Acid reducer
Treats frequent heartburn
occuring 2 or more days a week

**Compare to Prilosec OTC®

28 CAPSULES
Two 14-day courses of treatment

Omeprazole Delayed-Release Capsules, 20 mg, 14-count - Bottle Label

NDC: 0179-8104-14

KAISER PERMANENTE®

Omeprazole 
Delayed-release capsules
20 mg*
Acid reducer
Treats frequent heartburn 
occuring 2 or more days a week

**Compare to Prilosec OTC®

14 CAPSULES  
One 14-day course of treatment

INGREDIENTS AND APPEARANCE

OMEPRAZOLE MAGNESIUM 
omeprazole magnesium capsule, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0179-8104(NDC:55111-397)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OMEPRAZOLE MAGNESIUM (UNII: 426QFE7XLK) (omeprazole - UNII:KG60484QX9)	omeprazole	20 mg

Inactive Ingredients
Ingredient Name	Strength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
Gelatin (UNII: 2G86QN327L)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYPROMELLOSE 2208 (3 MPA.S) (UNII: 9H4L916OBU)
Magnesium Oxide (UNII: 3A3U0GI71G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2) (UNII: 5KY68S2577)
Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A (UNII: NX76LV5T8J)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
Polysorbate 80 (UNII: 6OZP39ZG8H)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SHELLAC (UNII: 46N107B71O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
RAW SUGAR (UNII: 8M707QY5GH)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
Sodium Lauryl Sulfate (UNII: 368GB5141J)

Product Characteristics
Color	WHITE, PINK	Score	no score
Shape	CAPSULE	Size	22mm
Flavor		Imprint Code	OMP20
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0179-8104-14	1 in 1 CARTON	01/01/2016
1		14 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 0179-8104-28	2 in 1 CARTON	01/01/2016
2		14 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 0179-8104-42	3 in 1 CARTON	01/01/2016
3		14 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078878	01/01/2016

Labeler - Kaiser Permanente (053052619)