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  5. Label Information: Sunmark Stomach Relief

FDA Label for Sunmark Stomach Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TABLET)
    2. PURPOSE
    3. OTC - KEEP OUT OF REACH OF CHILDREN
    4. USES
    5. WARNINGS
    6. DO NOT USE IF YOU HAVE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    9. WHEN USING THIS PRODUCT
    10. STOP USE AND ASK A DOCTOR IF
    11. IF PREGNANT OR BREAST-FEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE.
    12. DIRECTIONS
    13. INACTIVE INGREDIENTS
    14. PRINCIPAL DISPLAY PANEL

Sunmark Stomach Relief Product Label

The following document was submitted to the FDA by the labeler of this product Strategic Sourcing 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 (In Each Tablet)



Bismuth subsalicylate 262 mg

(total salicylate 102 mg per tablet)


Purpose



Upset stomach reliever and anti-diarrheal


Otc - Keep Out Of Reach Of Children





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 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 stools
  • 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



  • 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 fluids to help prevent dehydration which may accompany diarrhea.
    • Other information: each tablet contains:

    • salicylate 102 mg
    • calcium 140 mg
    • sodium free
    • avoid excessive heat (over 104˚F or 40˚C)
    • TAMPER EVIDENT: Do not use if individual compartments are torn or missing.

Inactive Ingredients



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


Principal Display Panel



sunmark

COMPARE TO PEPTO-BISMOL®CHEWABLE TABLETS ACTIVE INGREDIENT

stomach relief tablets

Regular Strength

Antidiarrheal/Upset Stomach Reliever

Soothing relief for upset stomach, nausea

heartburn, indigestion and diarrhea

BISMUTH SUBSALICYLATE 262 mg

CHEWABLE

30 TABLETS

Bismuth carton image 1

Bismuth carton image 2


* Please review the disclaimer below.