1. Home
  2. Labeler Index
  3. Proficient Rx Lp
  4. 63187-650
  5. Label Information: Bismatrol

FDA Label for Bismatrol

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TABLET)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE IF YOU HAVE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. INACTIVE INGREDIENTS
    13. PRINCIPAL DISPLAY PANEL

Bismatrol Product Label

The following document was submitted to the FDA by the labeler of this product Proficient Rx Lp. 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)



Bismuth subsalicylate 262 mg

(total salicylate 102 mg per tablet)


Purpose



Upset stomach reliever and anti-diarrheal


Uses



relieves:

  • •diarrhea
  • •heartburn
  • •indigestion
  • •nausea
  • •upset stomach associated with these symptoms

Warnings



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

Do Not Use If You Have



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

Ask A Doctor Before Use If You Have



  • •fever
  • •mucus in the stool

Ask A Doctor Or Pharmacist Before Use If You Are



taking any drug for

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

When Using This Product



a temporary, but harmless darkening of the stool and/or tongue may occur.


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

Keep Out Of Reach Of Children



Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.


Directions



  • •chew or dissolve in mouth
  • •adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed
  • •do not take more than 8 doses (16 tablets) in 24 hours
  • •children under 12 years: ask a doctor
  • •drink plenty of fluids to help prevent dehydration which may accompany diarrhea.

    • Other information: each tablet contains:

    • •sodium less than 1 mg
    • •salicylate 102 mg
    • •calcium 140 mg
    • •very low sodium
    • •avoid excessive heat (over 104˚F or 40˚C)
    • •TAMPER EVIDENT: Do not use if individual compartments are torn or missing.

Inactive Ingredients



calcium carbonate, D and C red 27 aluminum lake, flavor, magnesium stearate, mannitol, pregelatinized starch, saccharin sodium.


Principal Display Panel



MAJOR

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

Bismatrol Chewable Tablets

soothing, coating action provides fast relief for heartburn, indigestion, nausea, upset stomach and diarrhea

compare to the active ingredient in Pepto-Bismol®

30 chewable tablets

63187-650-30 - MF122

63187-650-30 - MF122


* Please review the disclaimer below.