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  5. Label Information: Careone Stomach Relief

FDA Label for Careone Stomach Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT(S)
    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 INGRADIENTS
    15. PRINCIPAL DISPLAY PANEL

Careone Stomach Relief Product Label

The following document was submitted to the FDA by the labeler of this product Retail Business 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(S)



Bismuth subsalicylate 262 mg (total salicylate 102 mg per tablet)


Purpose



Upset stomach reliever and anti-diarrheal


Use(S)



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 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 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 clear fluids to help prevent dehydration caused by diarrhea 

Other Information



  • each tablet contains:
  • sodium less than 1 mg 
  • salicylate 102 mg
  • very low sodium 
  • avoid excessive heat (over 104oF or 40oC).
  • TAMPER EVIDENT: Do not use if individual compartments are torn or open.

Inactive Ingradients



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


Principal Display Panel



C 72476-173-72

CAREoneTM

Compare to active ingredient of Pepto-Bismol® Chewable Tablets*

Stomach Relief Tablets

Bismuth Subsalicylate 262 mg

Upset Stomach/Antidiarrheal

EASY TO CHEW

FOR RELIEF OF:

* Please review the disclaimer below.