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NDC 00113-0022-39 Good Sense Heartburn Relief 200 mg/1 Details
Good Sense Heartburn Relief 200 mg/1
Good Sense Heartburn Relief is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by L. Perrigo Company. The primary component is CIMETIDINE.
MedlinePlus Drug Summary
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 food pipe (esophagus); and conditions where the stomach produces too much acid, such as Zollinger-Ellison syndrome. Over-the-counter cimetidine is used to prevent and treat symptoms of heartburn associated with acid indigestion and sour stomach. Cimetidine is in a class of medications called H2 blockers. It decreases the amount of acid made in the stomach.
Related Packages: 00113-0022-39Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Cimetidine
Product Information
| NDC | 00113-0022 |
|---|---|
| Product ID | 0113-0022_8a4c54d0-c24b-4e16-8a7b-67a3a0e3b727 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Good Sense Heartburn Relief |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Cimetidine |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 200 |
| Active Ingredient Units | mg/1 |
| Substance Name | CIMETIDINE |
| Labeler Name | L. Perrigo Company |
| Pharmaceutical Class | Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA075285 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00113-0022-39 (00113002239)
| NDC Package Code | 0113-0022-39 |
|---|---|
| Billing NDC | 00113002239 |
| Package | 1 BOTTLE in 1 CARTON (0113-0022-39) / 30 TABLET, FILM COATED in 1 BOTTLE |
| Marketing Start Date | 2002-12-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL f78c4813-0036-4d3b-8339-8eb00026c50c Details
Uses
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.
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 ingredients
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
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
INGREDIENTS AND APPEARANCE
| GOOD SENSE HEARTBURN RELIEF
cimetidine tablet, film coated |
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| Labeler - L. Perrigo Company (006013346) |