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Good sense heartburn relief - Medication Information

Product NDC Code 0113-0022
Drug Name

Good sense heartburn relief

Type Brand
Pharm Class Histamine H2 Receptor Antagonists [MoA],
Histamine-2 Receptor Antagonist [EPC]
Active Ingredients
Cimetidine 200 mg/1
Route ORAL
Dosage Form TABLET, FILM COATED
RxCUI drug identifier 197505
Application Number ANDA075285
Labeler Name L. Perrigo Company
Packages
Package NDC Code Description
0113-0022-39 1 bottle in 1 carton (0113-0022-39) / 30 tablet, film coated in 1 bottle
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (in each tablet) Cimetidine 200 mg

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate, titanium dioxide

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
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 foods and beverages

Purpose

Information about the drug product’s indications for use.
Purpose Acid reducer

Spl product data elements

Usually a list of ingredients in a drug product.
Good Sense Heartburn Relief Cimetidine CIMETIDINE CIMETIDINE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 POVIDONE, UNSPECIFIED SODIUM LAURYL SULFATE TITANIUM DIOXIDE L022

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Principal Display Panel Heartburn Prevention Heartburn Relief Actual Size Cimetidine Tablets, 200 mg Acid Reducer JUST ONE TABLET RELIEVES and PREVENTS Heartburn and Acid Indigestion Take ANYTIME You Need It: Before Meal During Meal After Meal Compare to active ingredient of Tagamet® HB 200 100% SATISFACTION GUARANTEED 30 Tablets (30 Doses) Read and retain the important information and drug interaction warnings printed on the product information sheet 022-c2-heartburn-relief.jpg

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Consumer Information Cimetidine Tablets, 200 mg Acid Reducer For Heartburn In clinical studies, Cimetidine Tablets, 200 mg was significantly better than placebo tablets in relieving and preventing heartburn symptoms. Percent of Heartburn Episodes Relieved Percent of Patients with Prevention or Reduction of Heartburn Symptoms When Taken 30 Minutes Before a Meal Percent of Patients with Prevention or Reduction of Heartburn Symptoms When Taken at Time of Meal Drug Interaction Warnings: Cimetidine Tablets, 200 mg 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 Cimetidine Tablets, 200 mg on any other medicines you are taking, talk to your doctor or pharmacist. 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 stomach Read the directions and warnings before taking this medication. Questions or Comments? 1-800-719-9260 Distributed By Perrigo® Allegan, MI 49010 Rev 08/19 02200 00 J5 Chart Image Chart Image Chart Image
THEOPHYLLINE THEO-DUR® Theochron® Slo-Bid® Uniphyl® Theo-24®
WARFARIN Coumadin®
PHENYTOIN Dilantin®

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
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 • kidney disease • liver disease

Ask doctor or pharmacist

Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.
Ask a doctor or pharmacist before use if you are taking • a prescription drug. Acid reducers may interact with certain prescription drugs.

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
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

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
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).

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? 1-800-719-9260

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
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

Pregnancy or breast feeding

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

Storage and handling

Information about safe storage and handling of the drug product.
Other information • store at 20°-25°C (68°-77°F)

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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 • kidney disease • liver disease Ask 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 • 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 (1-800-222-1222).

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API