NDC 0113-0022 Good Sense Heartburn Relief

Cimetidine

NDC Product Code 0113-0022

NDC CODE: 0113-0022

Proprietary Name: Good Sense Heartburn Relief 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: Cimetidine 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.

  • Cimetidine is used to treat ulcers of the stomach and intestines and prevent them from coming back after they have healed. This medication is also used to treat certain stomach and throat (esophagus) problems caused by too much stomach acid (e.g., Zollinger-Ellison syndrome, erosive esophagitis) or a backward flow of stomach acid into the esophagus (acid reflux disease/GERD). Decreasing extra stomach acid can help relieve symptoms such as stomach pain, heartburn, difficulty swallowing, persistent cough, and trouble sleeping. It can also prevent serious acid damage to your digestive system (e.g., ulcers, cancer of the esophagus). Cimetidine belongs to a class of drugs commonly called H2 blockers. It works by reducing the amount of acid in your stomach. This medication is also available without a prescription. It is used to treat occasional heartburn caused by too much acid in the stomach (also called acid indigestion or sour stomach). It is also used to prevent heartburn and acid indigestion caused by certain foods and beverages. If you are taking this medication for self-treatment, it is important to read the manufacturer's package instructions carefully so you know when to consult your doctor or pharmacist. (See also Precautions.)

Product Characteristics

Color(s):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
13 MM
Imprint(s):
L022
Score: 1

NDC Code Structure

  • 0113 - L. Perrigo Company

NDC 0113-0022-39

Package Description: 1 BOTTLE in 1 CARTON > 30 TABLET, FILM COATED in 1 BOTTLE

NDC Product Information

Good Sense Heartburn Relief with NDC 0113-0022 is a a human over the counter drug product labeled by L. Perrigo Company. The generic name of Good Sense Heartburn Relief is cimetidine. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: L. Perrigo Company

Dosage Form: Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.

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.

Good Sense Heartburn Relief 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.

  • CIMETIDINE 200 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.

  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • POVIDONES (UNII: FZ989GH94E)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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.
  • 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: L. Perrigo Company
Labeler Code: 0113
FDA Application Number: ANDA075285 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: ANDA - A product marketed under an approved Abbreviated 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: 12-30-2002 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: 12-31-2021 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’.

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Information for Patients

Cimetidine

Cimetidine is pronounced as (sye met' i deen)

Why is cimetidine medication prescribed?
Cimetidine is used to treat ulcers; gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and injury of the...
[Read More]

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Good Sense Heartburn Relief 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)

Cimetidine 200 mg

Purpose

Acid reducer

Uses

  • •relieves heartburn associated with acid indigestion and sour stomach •prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages

Warnings

Allergy alert: Do not use if you are allergic to cimetidine or other acid reducers

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. •with other acid reducers

Ask A Doctor Before Use If You Have

  • •frequent chest pain •frequent wheezing, particularly with heartburn •unexplained weight loss •nausea or vomiting •stomach pain •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

Ask A Doctor Or Pharmacist Before Use If You Are

  • Taking •theophylline (oral asthma medicine) •warfarin (blood thinning medicine) •phenytoin (seizure medicine)If you are not sure you are taking one of these medicines, talk to your doctor or pharmacist.

Stop Use And Ask A Doctor If

  • •your heartburn continues or worsens •stomach pain continues •you need to take this product for more than 14 days

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 and children 12 years and over: •to relieve symptoms, swallow 1 tablet with a glass of water •to prevent symptoms, swallow 1 tablet with a glass of water right before or any time up to 30 minutes before eating food or drinking beverages that cause heartburn •do not take more than 2 tablets in 24 hours •children under 12 years: ask a doctor

Other Information

  • •do not use if printed foil under cap is broken or missing •store at 20°-25°C (68°-77°F)

Inactive Ingredients

Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate, titanium dioxide

Consumer Information

  • Cimetidine Tablets, 200 mgAcid ReducerFor HeartburnJust one Cimetidine Tablet, 200 mg relieves and prevents heartburn and acid indigestion.This product reduces the production of stomach acid that can cause heartburn.In clinical studies, Cimetidine Tablets, 200 mg was significantly better than placebo tablets in relieving and preventing heartburn symptoms.And Cimetidine Tablets, 200 mg is approved to take before, during, or after a meal.Percent of Heartburn Episodes RelievedPercent of Patients with Prevention or Reduction of Heartburn Symptoms When Taken 30 Minutes Before a MealPercent of Patients with Prevention or Reduction of Heartburn Symptoms When Taken at Time of MealDrug Interaction Warnings:This product affects some prescription medicines causing slightly higher levels of those medicines in the blood. Higher blood levels could lead to side effects in rare situations. If you currently take Theophylline (oral asthma medicine), Warfarin (blood thinning medicine) or Phenytoin (seizure medicine), consult your doctor before taking this product.Brand names of some medicines which contain one of these ingredients include:THEOPHYLLINE THEO-DUR® Theochron® Slo-Bid® Uniphyl® Theo-24®WARFARIN Coumadin®PHENYTOIN Dilantin®There may be other medicines that contain one of these ingredients. If in doubt about this or about possible effects of this product on any other medicines you are taking, talk to your doctor or pharmacist.For Prevention and Relief of Heartburn •To prevent heartburn symptoms, take Cimetidine Tablet, 200 mg before your first bite or any time up to 30 minutes before eating food or drinking beverages that may cause heartburn. •To relieve heartburn symptoms and for relief of acid indigestion and sour stomach, take Cimetidine Tablet, 200 mg at the first signs of discomfort.Tips for Managing Heartburn •Do not lie flat or bend over soon after eating •Do not eat late at night, or just before bedtime •Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables •Eat slowly and do not eat big meals •If you are overweight, lose weight •If you smoke, quit smoking •Raise the head of your bed •Wear loose fitting clothing around your stomachREAD THE LABELRead the directions and warnings before taking this medication.Questions or comments? 1-800-719-9260Distributed ByPerrigo®Allegan, MI 49010perrigo.comRev. Date: 11/0802200 00 J4

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