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  5. Label Information: Leader Stomach Relief

FDA Label for Leader Stomach Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT(IN EACH 30 ML)
    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

Leader Stomach Relief Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health 110, Llc. Dba Leader. 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 30 Ml)



Bismuth subsalicylate 525 mg



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



  • an ulcer
  • bloody or black stool
  • 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



  • shake well before use
  • mL = milliliter
  • TBSP = tablespoon
  • adults and children 12 years and over: 1 dose (2 TBSP or 30 mL) every 1/2 to 1 hour as needed
  • do not exceed 8 doses (16 TBSP or 240 mL) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • children under 12 years: ask a doctor
  • drink plenty of fluids to help prevent dehydration caused by diarrhea

Other Information



  • each 30 mL or 2 TBSP contains:
  • potassium 25 mg
  • salicylate 260 mg
  • sodium 8 mg
  • protect from freezing
  • avoid excessive heat (over 104oF or 40oC)
  • dosage cup provided

Inactive Ingredients



benzoic acid, D&C red # 22, D&C red # 28, flavor, hydroxyethyl cellulose, potassium hydroxide, purified water, saccharin sodium, salicylic acid, simethicone, xanthan gum


Principal Display Panel



LEADER™
NDC 70000-0439-2
Stomach Relief
Bismuth Subsalicylate, 525 mg

Upset Stomach Reliever/Anti-diarrheal

5 Symptom Digestive Relief:
Diarrhea, Heartburn, Indigestion, Nausea & Upset Stomach


COMPATE TO PEPTO-BISMOL active ingredient*

8 FL OZ (236 mL) 


527 - 527 236

527 - 527 236




* Please review the disclaimer below.