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  5. Label Information: Stomach Relief

FDA Label for Stomach Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH 15 ML TBSP)
    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 TAKING ANY DRUG FOR
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. IF PREGNANT OR BREAST FEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. PRINCIPAL DISPLAY PANEL

Stomach Relief Product Label

The following document was submitted to the FDA by the labeler of this product Winco Foods, 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 15 Ml Tbsp)



Bismuth subsalicylate 262 mg


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 children 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 A 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
  • for accurate dosing, use dose cup
  • 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 clear fluids to help prevent dehydration caused by diarrhea

Other Information



  • each Tbsp contains: sodium 5 mg, salicylate 130 mg, potassium 15 mg
  • protect from freezing
  • avoid excessive heat (over 104oF or 40oC)
  • TAMPER EVIDENT: Do not use if imprinted shrinkband is missing or broken.

Inactive Ingredients



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


Principal Display Panel



*Compare to the active ingredient in PEPTO-BISMOL®

WinCo Foods

Stomach Relief

Bismuth Subsalicylate / Upset stomach reliever & Anti-Diarrheal

Soothing Relief for:  Upset Stomach, Indigestion, Nausea, Heartburn & Diarrhea

8 FL OZ (236 mL)

Label - WC527

Label - WC527


* Please review the disclaimer below.