FDA Label for Moore Medical Bismuth

View Indications, Usage & Precautions

Moore Medical Bismuth Product Label

The following document was submitted to the FDA by the labeler of this product Moore Medical 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.

Other



Drug Facts

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's Syndrome a rare but serious illness.

Allergy alert: Contains salicylate. Do not take if you are:

  • allergic to salicylates (including aspirin)
  • taking other salicylate products
  • Adults and children: (12 years and older) Take 2 tablets every 1/2 to 1 hour or 4 tablets every hour as needed

    Children under 12 years: Do not give to children under 12 years of age.


Active Ingredient (In Each Tablet)



Bismuth Subsalicylate 262mg


Purpose



Upset stomach reliever/Antidiarrheal


Temporarily Relieves



  • traveler's diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
  • heartburn
  • indigestion
  • nausea
  • gas
  • belching
  • fullness

Do Not Use If You Have



  • bloody or black stool
  • an ulcer
  • a bleeding problem

Ask A Doctor Before Use If You Have



  • fever
  • mucus in the stool

Ask A Doctor Or Pharmacist If You Are Taking Any Drug For



  • anticoagulation (thinning of the blood)
  • diabetes
  • gout
  • arthritis

Stop Use And Ask A Doctor If



  • symptoms get worse
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 days
  • When using this product a temporary and harmless darkening of the tongue and/or stool may occur. Stool darkening should not be confused with melena.


Otc - Keep Out Of Reach Of Children



Keep this and all drugs out of reach of children. In case of accidental overdose, contact a physician or poison control center immediately.


Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Directions



  • do not use more than directed
  • chew or dissolve in mouth
  • use until diarrhea stops but not more than 2 days
  • drink plenty of clear fluids to help prevent dehydration, which may accompany diarrhea
  • do not exceed 16 tablets in 24 hours

Other Information



  • phenylketonurics: contains phenylalanine 1.1mg per tablet
  • each tablet contains 73mg elemental calcium
  • store at room temperature 59°-86°F (15°-30°C)
  • tamper-evident sealed packets
  • do not use any opened or torn packets

Inactive Ingredients



acacia gum, aspartame, calcium carbonate, D&C red #27, dextrates, flavoring, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide


220R Moore Medical Bismuth Label



moore medical

Supporting Health and Care

UPN# 0-0607415-82473-5

Moore Brand®

Bismuth Tablets

100 Packets/2 Tablets

Controls diarrhea within 24 hours,
relieving associated abdominal cramps;
provides soothing relief for:
indigestion, upset stomach, heartburn and nausea.

To Reorder:

Call: 800.234.1464

Fax: 800.944.6667

Online: www.mooremedical.com


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