Prevacid description, usages, side effects, indications, overdosage, supplying and lots more!

Prevacid

Novartis Consumer Health, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
PREVACID 24 HRLansoprazole delayed-release capsules 15mg / acid reducer

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Lansoprazole 15mg 

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 lansoprazole

Do Not Use

  • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.

Ask Doctor

  • warfarin (blood-thinning medicine) 
  •  prescription antifungal or anti-yeast medicines 
  •  digoxin (heart medicine) 
  •  theophylline (asthma medicine) 
  •  tacrolimus (immune system medicine) 
  •  atazanavir (medicine for HIV infection)

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

If pregnant or breast feeding

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

In case of overdose

In case of overdose, get medical help or contact a Poison Control Center right away. 

Directions

  • 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, although 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 
    •  swallow whole. Do not crush or chew capsules. 
    •  do not use for more than 14 days unless directed by your doctor 

    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 before use. Heartburn in children may sometimes be caused by a serious condition.

Other information

  • read the directions, warnings and package insert before use 
  • keep the carton and package insert. They contain important information.
  • store at 20-250   C (68-77   F)
  • keep product out of high heat and humidity 
  • protect product from moisture

Inactive ingredients

colloidal silicon dioxide, D&C red No. 28, FD&C blue No. 1, FD&C green No. 3, FD&C red No. 40, gelatin, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, starch, sucrose, sugar sphere, talc, titanium dioxide

Questions or Comments?

Questions or comments? 1-800-452-0051

Distributed by: Novartis Consumer Health, Inc.,

Parsippany, NJ 07054-0622 ©2009 U.S. Patent No. 4,628,098

PREVACID® is a registered trademark of Takeda Pharmaceuticals North America, Inc.

Principal Display Panel

Principal Display Panel

Prevacid

Lansoprazole CAPSULE, DELAYED RELEASE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0067-6286
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
lansoprazole LANSOPRAZOLE 15 mg

Inactive Ingredients

Ingredient Name Strength
COLLOIDAL SILICON DIOXIDE
D&C RED NO. 28
FD&C BLUE NO. 1
FD&C GREEN NO. 3
FD&C RED NO. 40
GELATIN
hydroxypropyl cellulose
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
MAGNESIUM CARBONATE
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)
polyethylene glycol
polysorbate 80
STARCH, CORN
SUCROSE
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
PINK 16 mm P24HR CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0067-6286-14 14 in 1 BOTTLE
2 14 in 1 BOTTLE
3 14 in 1 BOTTLE
4 NDC:0067-6286-98 60000 in 1 DRUM
5 NDC:0067-6286-99 49500 in 1 DRUM
6 NDC:0067-6286-03 3 in 1 DRUM

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022327 2009-11-12


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