FDA Label for Pepcid Complete

View Indications, Usage & Precautions

Pepcid Complete Product Label

The following document was submitted to the FDA by the labeler of this product Jc World Bell Wholesale Co., Inc.. 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.

Drug Facts




Active Ingredients (In Each Chewable Tablet)



Famotidine 10 mg 
Calcium carbonate 800 mg 
Magnesium hydroxide 165 mg


Purposes



Acid reducer

Antacid


Use



relieves heartburn associated with acid indigestion and sour stomach


Warnings



Allergy alert: Do not use if you are allergic to famotidine 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



  • 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
  • frequent chest pain
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain
  • kidney disease

Ask A Doctor Or Pharmacist Before Use If You Are



taking a prescription drug. Antacids and acid reducers may interact with certain prescription drugs.


Stop Use And Ask A Doctor If



  • your heartburn continues or worsens
  • 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. (1-800-222-1222)


Directions



  • adults and children 12 years and over:
  • do not swallow tablet whole: chew completely
  • to relieve symptoms, chew 1 tablet before swallowing
  • do not use more than 2 chewable tablets in 24 hours
  • children under 12 years: ask a doctor

Other Information



  • each tablet contains: calcium 320 mg, magnesium 70 mg
  • read the directions and warnings before use
  • keep the carton. It contains important information. 
  • store at 20°-25°C (68°-77°F)
  • protect from moisture
  • do not use if pouch is torn or damaged

Inactive Ingredients



cellulose acetate, corn starch, crospovidone, D&C red no. 7 calcium lake, dextrose excipient, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, flavors, gum arabic, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, maltodextrin, mineral oil, modified starch, sucralose


Questions Or Comments?



1-800-755-4008 (toll-free) or 215-273-8755 (collect)


Package Labeling:Inner Package3




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