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  5. Label Information: Goodsense Maximum Strength Stomach Relief 528

FDA Label for Goodsense Maximum Strength Stomach Relief 528

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

Goodsense Maximum Strength Stomach Relief 528 Product Label

The following document was submitted to the FDA by the labeler of this product Good Sense (geiss, Destin & Dunn, Inc.). 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 1050 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 hour as needed
  • do not exceed 4 doses (8 TBSP or 120 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 15 mg
  • salicylate 471 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



NDC 50804-154-04

GOODSENSE®

Maximum Strength
Stomach Relief

Bismuth Subsalicylate 1050 mg

Antidiarrheal /Upset Stomach Reliever
Soothing Relief For 5 Symptoms

  • Upset Stomach
  • Indigestion
  • Heartburn
  • Nausea
  • Diarrhea

    • *Compare to the active ingredient of Pepto-Bismol ® Maximum Strength

      8 FL OZ (236  mL)

    528-goodsense.jpg - 528 goodsense

    528-goodsense.jpg - 528 goodsense



* Please review the disclaimer below.