Omeprazole tablet, orally disintegrating, delayed release

Active ingredient (in each tablet)

Omeprazole 20 mg

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 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
  • 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

  • take 1 tablet before eating in the morning
  • do not crush or chew tablets
  • place the tablet on tongue; tablet disintegrates, with or without water. The tablets can also be swallowed whole with water.
  • 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
  • do not take this medicine with alcohol

Repeated 14-Day Course (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 before use. 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 20-25C (68-77F); keep product out of high heat and moisture

Inactive ingredients

amino methacrylate copolymer, ascorbic acid, cetyl alcohol, colloidal silicon dioxide, crospovidone, ferric oxide, flavor, hypromellose, hypromellose phthalate, maize maltodextrin, mannitol, microcrystalline cellulose, propylene glycol, silicon dioxide, sodium stearate, sodium stearyl fumarate, sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate

Questions or comments?

1-800-719-9260:weekdays 7:30 AM to 5:00 PM EST

Ingredients and appearance - Product information

Omeprazole tablet, orally disintegrating, delayed release- Omeprazole

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 37012-711
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Omeprazole ( UNII: KG60484QX9)( Omeprazole - UNII: KG60484QX9 ) 20 mgin 1

Inactive Ingredients

Ingredient Name Code
Dimethylaminoethyl methacrylate - butyl methacrylate - methyl methacrylate copolymer ( UNII: 905HNO1SIH)
Ascorbic acid ( UNII: PQ6CK8PD0R)
Cetyl alcohol ( UNII: 936JST6JCN)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Crospovidone (15 mpa.s at 5%) ( UNII: 68401960MK)
Ferric oxide red ( UNII: 1K09F3G675)
Hypromelloses ( UNII: 3NXW29V3WO)
Mannitol ( UNII: 3OWL53L36A)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Propylene glycol ( UNII: 6DC9Q167V3)
Sodium stearate ( UNII: QU7E2XA9TG)
Sodium stearyl fumarate ( UNII: 7CV7WJK4UI)
Sorbitol ( UNII: 506T60A25R)
Sucralose ( UNII: 96K6UQ3ZD4)
Talc ( UNII: 7SEV7J4R1U)
Titanium dioxide ( UNII: 15FIX9V2JP)
Triethyl citrate ( UNII: 8Z96QXD6UM)

Product Characteristics

Color RED (reddish) Size 9 mm
Shape ROUND Score 1
Imprint Code 20 Flavor STRAWBERRY

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA209400 USA

Labeler - Shopko Stores Operating Co., LLC( 023252638)

Package/label principal display panel

Compare to Prilosec OTC ®

MELTech

Melts In Your Mouth

OMEPRAZOLE

DELAYED RELEASE ORALLY DISINTEGRATING TABLETS 20 mg

Acid Reducer

MELTS IN YOUR MOUTH

DISSOLVES WITHOUT WATER

Treats Frequent Heartburn!

Occurring 2 or More Days a Week

Strawberry Flavor

42 Tablets

THREE 14-DAY COURSES OF TREATMENT

Orally Disintegrating Tablets

Actual Size