NDC 55315-019 Lansoprazole

NDC Product Code 55315-019

NDC CODE: 55315-019

Proprietary Name: Lansoprazole What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Lansoprazole is used to treat certain stomach and esophagus problems (such as acid reflux, ulcers). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as heartburn, difficulty swallowing, and persistent cough. This medication helps heal acid damage to the stomach and esophagus, helps prevent ulcers, and may help prevent cancer of the esophagus. Lansoprazole belongs to a class of drugs known as proton pump inhibitors (PPIs). If you are self-treating with this medication, over-the-counter lansoprazole products are used to treat frequent heartburn (occurring 2 or more days a week). Since it may take 1 to 4 days to have full effect, these products do not relieve heartburn right away. For over-the-counter products, carefully read the package instructions to make sure the product is right for you. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar brand names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

Product Characteristics

Color(s):
PINK (C48328)
GREEN (C48329)
Shape: CAPSULE (C48336)
Size(s):
16 MM
Imprint(s):
W;140
Score: 1

NDC Code Structure

NDC 55315-019-14

Package Description: 1 BLISTER PACK in 1 BOX > 14 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Lansoprazole with NDC 55315-019 is a product labeled by Freds Inc. The generic name of Lansoprazole is . The product's dosage form is and is administered via form.

Labeler Name: Freds Inc

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GELATIN (UNII: 2G86QN327L)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • MAGNESIUM CARBONATE (UNII: 0E53J927NA)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • SUCROSE (UNII: C151H8M554)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Freds Inc
Labeler Code: 55315
Start Marketing Date: 12-04-2012 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2019 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I - INACTIVATED, the listing data was inactivated by the FDA. What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Information for Patients

Lansoprazole

Lansoprazole is pronounced as (lan soe' pra zole)

Why is lansoprazole medication prescribed?
Prescription lansoprazole is used to treat gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and possib...
[Read More]
Lansoprazole, Clarithromycin, and Amoxicillin

Lansoprazole, Clarithromycin, and Amoxicillin is pronounced as (lan soe' pra zole) (kla rith' roe mye sin) (a mox i sil' in)
Why is lansoprazole, clarithromycin, and amoxicillin medication prescribed?
Lansoprazole, clarithromycin, and amoxicillin are used to treat and prevent the return of ulcers (sores in the lining of the stomach or intestine) caused by a certain typ...
[Read More]

* Please review the disclaimer below.

Lansoprazole Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient (In Each Capsule)

Lansoprazole 15 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 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 painfrequent wheezing, particularly with heartburn
  • Unexplained weight loss
  • Nausea or vomiting
  • Stomach pain

Ask A Doctor Or Pharmacist Before Use If You Are

  • Takingwarfarin (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
  • 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

  • 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 hours14-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 doctorRepeated 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. Patients should use the lowest dose and shortest duration of this therapy.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

Colloidal silicon dioxide, D&C red No. 33, D&C yellow No. 10, FD&C blue No. 1, FD&C red No. 40, gelatin, hypromellose, magnesium carbonate, methacrylic acid copolymer dispersion, polyethylene glycol, polysorbate 80, sucrose, sugar spheres, talc, titanium dioxide

Product Label

Fred's 24 Hour Heartburn Relief Capsules

* Please review the disclaimer below.