FDA Label for Sunmark Heartburn Relief Acid Reducer
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE TAKING
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Sunmark Heartburn Relief Acid Reducer Product Label
The following document was submitted to the FDA by the labeler of this product Strategic Sourcing Services Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
Principal Display Panel
Compare to Tagamet HB 200® active ingredient
Heartburn Relief
Cimetidine Tablets USP, 200 mg
Acid Reducer
Just One Tablet Relieves and Prevents Heartburn and Acid Indigestion
Take Any Time you need it:
Before Meal
During Meal
After Meal
One Tablet Dose
Actual Size
(# Doses) {Replace "#" with number of tablets in package}
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