Good Sense Heartburn Relief

GOOD SENSE HEARTBURN RELIEF- cimetidine tablet
Bryant Ranch Prepack

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

Questions or comments?

1-800-719-9260

Consumer Information

Cimetidine Tablets, 200 mg

Acid Reducer

For Heartburn

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

Chart Image

Percent of Patients with Prevention or Reduction of Heartburn Symptoms When Taken 30 Minutes Before a Meal

Chart Image

Percent of Patients with Prevention or Reduction of Heartburn Symptoms When Taken at Time of Meal

Chart Image

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:

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 stomach

READ THE LABEL

Read the directions and warnings before taking this medication.

Questions or comments? 1-800-719-9260

Cimetidine 200mg Tablet

Label
(click image for full-size original)
GOOD SENSE HEARTBURN RELIEF
cimetidine tablet
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 (CIMETIDINE) CIMETIDINE 200 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
POLYSORBATE 80
POVIDONES
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 13mm
Flavor Imprint Code L022
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63629-4203-1 20 TABLET in 1 BOTTLE None
2 NDC:63629-4203-2 90 TABLET in 1 BOTTLE None
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 Operations
Bryant Ranch Prepack 171714327 REPACK (63629-4203), RELABEL (63629-4203)

Revised: 01/2013 Bryant Ranch Prepack

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