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| Product NDC Code | 0113-0022 | ||||
|---|---|---|---|---|---|
| Drug Name | Good sense heartburn relief |
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| Type | Brand | ||||
| Pharm Class | Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET, FILM COATED | ||||
| RxCUI drug identifier | 197505 | ||||
| Application Number | ANDA075285 | ||||
| Labeler Name | L. Perrigo Company | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
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
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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 feedingIf 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