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Lansoprazole by Gericare Pharmaceuticals

Medically reviewed on December 7, 2017

Dosage form: capsule, delayed release
Ingredients: Lansoprazole 15mg
Labeler: Gericare Pharmaceuticals
NDC Code: 57896-761

Lansoprazole Delayed Release Capsules USP

Active ingredient(s)

Lansoprazole  USP, 15 mg

Purpose

Acid reducer

Use(s)
  • 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 a doctor before use if you have
  • liver disease
  • had heartburn over 3 months. This may be a sign of a more serious condition.
  • 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
  • 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 (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 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. (1-800-222-1222)

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 days
  • 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° – 25°C (68° – 77° F)
  • keep product out of high heat and humidity
  • protect product from moisture

Inactive ingredients

FD&C Blue No. 2, gelatin, hydroxypropyl cellulose, iron oxide black, iron oxide red, iron oxide yellow, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol 6000, polysorbate 80, sodium lauryl sulphate, starch (corn), sucrose, sugar spheres, talc, titanium dioxide

Questions or comments?

call 1-888-375-3784

Manufactured by:

Dr. Reddy’s Laboratories Limited

Bachupally - 500 090 INDIA

Principal Display Panel - container carton

Container carton : 14's count

LANSOPRAZOLE  
lansoprazole capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-761(NDC:55111-739)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lansoprazole (Lansoprazole) Lansoprazole15 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 2 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
GELATIN 
HYDROXYPROPYL CELLULOSE 
FERROSOFERRIC OXIDE 
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED 
MAGNESIUM CARBONATE 
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A 
POLYETHYLENE GLYCOL 6000 
POLYSORBATE 80 
SODIUM LAURYL SULFATE 
STARCH, CORN 
SUCROSE 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorPINK (opaque pink colored cap) , GREEN (opaque green colored body) Scoreno score
ShapeCAPSULESize3mm
FlavorImprint CodeRDY;398
Contains    
Packaging
#Item CodePackage Description
1NDC:57896-761-423 BOTTLE in 1 PACKAGE, COMBINATION
114 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20219404/25/2013
Labeler - Gericare Pharmaceuticals (611196254)

 
Gericare Pharmaceuticals

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Further information

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

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