NDC 30142-192 Lansoprazole

Lansoprazole

NDC Product Code 30142-192

NDC Code: 30142-192

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: Lansoprazole 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.


Product Characteristics
Color(s):
WHITE (C48325 - OFF WHITE MOTTLED)
Shape: ROUND (C48348)
Size(s):
9 MM
Imprint(s):
15
Score: 1

Code Structure
  • 30142 - Kroger Company
    • 30142-192 - Lansoprazole

NDC 30142-192-55

Package Description: 3 CARTON in 1 CARTON > 14 BLISTER PACK in 1 CARTON > 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK

NDC Product Information

Lansoprazole with NDC 30142-192 is a a human over the counter drug product labeled by Kroger Company. The generic name of Lansoprazole is lansoprazole. The product's dosage form is tablet, orally disintegrating, delayed release and is administered via oral form.

Labeler Name: Kroger Company

Dosage Form: Tablet, Orally Disintegrating, Delayed Release - A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue, but which releases a drug (or drugs) at a time other than promptly after administration.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.


Lansoprazole Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • LANSOPRAZOLE 15 mg/1

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.

  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • COPOVIDONE K25-31 (UNII: D9C330MD8B)
  • CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • MALTITOL (UNII: D65DG142WK)
  • MANNITOL (UNII: 3OWL53L36A)
  • MEGLUMINE (UNII: 6HG8UB2MUY)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
  • SORBITOL (UNII: 506T60A25R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

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

Labeler Name: Kroger Company
Labeler Code: 30142
FDA Application Number: NDA208025 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 04-05-2019 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: 12-31-2020 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: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Lansoprazole Product Label Images

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 Tablet)

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 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 or mycophenolate mofetil (immune system medicines) •atazanavir (medicine 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

  • •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 •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 alcoholRepeated 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, 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

Ascorbic acid, cetyl alcohol, colloidal silicon dioxide, copovidone, crospovidone, flavor, hypromellose, hypromellose phthalate, maize maltodextrin, maltitol, mannitol, meglumine, microcrystalline cellulose, polysorbate 80, propylene glycol, silicon dioxide, sodium stearyl fumarate, sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate

Consumer Information

  • Treats Frequent HeartburnLansoprazoleDelayed ReleaseOrally Disintegrating Tablets 15 mgacid reducer • May take 1 to 4 days for full effectPlease read the entire package insert before taking Lansoprazole Delayed Release Orally Disintegrating Tablets.Save for future reference.How Lansoprazole delayed release orally disintegrating tablets Treats Your Frequent HeartburnLansoprazole delayed release orally disintegrating tablets stops acid production at the source - the pumps that release acid into the stomach. Lansoprazole delayed release orally disintegrating tablet is taken once a day (every 24 hours), every day for 14 days.What You Can Expect When Taking Lansoprazole delayed release orally disintegrating tabletsFrequent heartburn can occur anytime during the 24-hour period (day or night). Take Lansoprazole delayed release orally disintegrating tablets in the morning before eating. Lansoprazole is clinically proven to treat frequent heartburn. Although some people get complete relief of symptoms within 24 hours, it may take 1 to 4 days for full effect. Make sure you take Lansoprazole delayed release orally disintegrating tablets every day for 14 days to treat your frequent heartburn.Who Should Take Lansoprazole delayed release orally disintegrating tabletsAdults (18 years and older) with frequent heartburn - when you have heartburn 2 or more days a week.Who Should NOT Take Lansoprazole delayed release orally disintegrating tabletsPeople who have one episode of heartburn a week or less, or who want immediate relief of heartburn.How to Take Lansoprazole delayed release orally disintegrating tablets 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.When to Take Lansoprazole delayed release orally disintegrating tablets AgainYou may repeat a 14-day course of therapy every 4 months.When to Talk to Your DoctorDo not take for more than 14 days or more often than every 4 months unless directed by a doctor.Warnings and When to Ask Your DoctorAllergy alert: Do not use if you are allergic to lansoprazoleDo 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 painAsk a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.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 painIf pregnant or breast-feeding, ask a health care 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).Tips for Managing Heartburn •Avoid foods or drinks that are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some acidic fruits and vegetables. •Eat slowly and do not eat big meals. •Do not eat late at night or just before bedtime. •Do not lie flat or bend over soon after eating. •Raise the head of your bed. •Wear loose-fitting clothing around your stomach. •If you are overweight, lose weight. •If you smoke, quit smoking.Clinical studies prove that lansoprazole effectively treats frequent heartburnIn three clinical studies, lansoprazole was shown to be significantly better than placebo in treating frequent heartburn.How Lansoprazole delayed release orally disintegrating tablets is SoldThis medicine is available in 14 tablet, 28 tablet and 42 tablet sizes. These sizes contain one, two and three 14-day courses of treatment, respectively. Do not use for more than 14 days in a row unless directed by your doctor. For the 28 count (two 14-day courses) and the 42 count (three 14-day courses), you may repeat a 14-day course every 4 months.For Questions or Comments About Lansoprazole delayed release orally disintegrating tabletsCall 1-800-719-9260weekdays 7:30 AM to 5:00 PM ESTMade in IsraelManufactured by:Dexcel Pharma Technologies Ltd10 Hakidma Street, Yokneam 2069200, Israel:8U100 00 J21249460078-AOR :8U17400J2

* Please review the disclaimer below.

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