Label: GOOD SENSE HEARTBURN RELIEF- cimetidine tablet
- NDC Code(s): 63629-4203-1, 63629-4203-2
- Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 0113-0022
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated January 21, 2013
If you are a consumer or patient please visit this version.
- Active ingredient (in each tablet)
Cimetidine 200 mgClose
- 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
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
- 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
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
- 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 dioxideClose
- Questions or comments?
- Consumer Information
Cimetidine Tablets, 200 mg
Just 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 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:
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:
THEO-DUR® Theochron® Slo-Bid® Uniphyl® Theo-24®
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 stomach
READ THE LABEL
Read the directions and warnings before taking this medication.
Questions or comments? 1-800-719-9260Close
- PRINCIPAL DISPLAY PANEL
Cimetidine 200mg TabletClose
- INGREDIENTS AND APPEARANCE
GOOD SENSE HEARTBURN RELIEF
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-4203(NDC:0113-0022) Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CIMETIDINE (UNII: 80061L1WGD) (CIMETIDINE - UNII:80061L1WGD) CIMETIDINE 200 mg Inactive Ingredients Ingredient Name Strength 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) Product Characteristics Color WHITE Score no score Shape ROUND Size 13mm Flavor Imprint Code L022 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63629-4203-1 20 in 1 BOTTLE 2 NDC:63629-4203-2 90 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075285 12/30/2002 Labeler - Bryant Ranch Prepack (171714327) Registrant - Bryant Ranch Prepack (171714327) Establishment Name Address ID/FEI Business Operations Bryant Ranch Prepack 171714327 REPACK(63629-4203) , RELABEL(63629-4203)