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  5. Label Information: Topco Stomach Relief

FDA Label for Topco Stomach Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT(IN EACH CAPLET)
    2. PURPOSE
    3. USE(S)
    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 DOCTOR IF
    10. IF PREGNANT OR BREAST-FEEDING,
    11. KEEP OUT OF REACH OF CHILDREN
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. PRINCIPAL DISPLAY PANEL

Topco Stomach Relief Product Label

The following document was submitted to the FDA by the labeler of this product Topco Associates, 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 Caplet)



Bismuth subsalicylate 262 mg




Purpose



Upset stomach reliever and anti-diarrheal


Use(S)



relieves:


  • indigestion
  • nausea
  • heartburn
  • diarrhea
  • 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 behaviour 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 stool
  • 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 Doctor If



  • symptoms get worse
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 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



  • swallow caplet(s) with water, do not chew
  • adults and children 12 years and over: 2 caplets every 1/2 to 1 hour as needed
  • do not take more than 8 doses (16 tablets) in 24 hours
  • use until diarrhea stops but not more than 2 days 
  • children under 12 years: ask a doctor
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Other Information



  • each caplet contains:
  • calcium 27 mg, salicylate 102 mg and sodium 2 mg
  • very low sodium
  • TAMPER EVIDENT: do not use if printed seal under cap is torn or missing 
  • store at room temperature, in a dry place

Inactive Ingredients



calcium carbonate, colloidal silicon dioxide, D&C red 27 lake, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, sodium starch glycolate.


Principal Display Panel



Topcare health

COMPATE TO PEPTO-BISMOL®  ACTIVE INGREDIENT*

NDC 36800-104-28

Stomach Relief
BISMUTH SUBSALICYLATE 262 mg
UPSET STOMACH RELIEVER / ANTIDIARRHEAL

5 SYMPTOM RELIEF 

  • Nausea
  • Heartburn
  • Indigestion
  • Upset stomach
  • Diarrhea

    • 40 CAPLETS

    64 - 172

    64 - 172





* Please review the disclaimer below.