FDA Label for Sunmark Heartburn Relief Acid Reducer

View Indications, Usage & Precautions

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


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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}

Heartburn Relief Carton

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