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  5. Label Information: Bismuth Subsalicylate

FDA Label for Bismuth Subsalicylate

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENT (IN EACH SOFTGEL) BISMUTH SUBSALICYLATE 262 MG
    3. PURPOSE UPSET STOMACH RELIEVER AND ANTI-DIARRHEAL
    4. USES RELIEVES • TRAVELERS' DIARRHEA • DIARRHEA • UPSET STOMACH DUE TO OVERINDULGENCE IN FOOD AND DRINK, INCLUDING: • HEARTBURN • INDIGESTION • NAUSEA • GAS • BELCHING • FULLNESS
    5. WARNINGSREYE'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
    6. DO NOT USE IF YOU HAVE • AN ULCER • A BLEEDING PROBLEM • BLOODY OR BLACK STOO
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE • FEVER • MUCUS IN THE STOOL
    8. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARETAKING ANY DRUG FOR • ANTICOAGULATION (THINNING THE BLOOD) • DIABETES • GOUT • ARTHRITIS
    9. WHEN USING THIS PRODUCTA TEMPORARY, BUT HARMLESS, DARKENING OF THE STOOL AND/OR TONGUE MAY OCCUR
    10. STOP USE AND ASK A DOCTOR IF • SYMPTOMS GET WORSE OR LAST MORE THAN 2 DAYS • RINGING IN THE EARS OR LOSS OF HEARING OCCURS • DIARRHEA LASTS MORE THAN 2 DAYS
    11. IF PREGNANT OR BREAST-FEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE.
    12. KEEP OUT OF REACH OF CHILDREN.IN CASE OF OVERDOSE, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
    13. DIRECTIONS • SWALLOW WITH WATER, DO NOT CHEW • ADULTS AND CHILDREN 12 YEARS AND OVER: • 2 SOFTGELS EVERY ½ HOUR OR 4 SOFTGELS EVERY HOUR AS NEEDED FOR DIARRHEA • 2 SOFTGELS EVERY ½ HOUR TO 1 HOUR AS NEEDED FOR OVERINDULGENCE (UPSET STOMACH, HEARTBURN, INDIGESTION, NAUSEA) • DO NOT EXCEED 8 DOSES (16 SOFTGELS) 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
    14. OTHER INFORMATIONEACH SOFTGEL CONTAINS:SALICYLATE 102 MG • VERY LOW SODIUM • DO NOT EXCEED 25°C
    15. INACTIVE INGREDIENTS AEROSIL, BEESWAX, D&C RED#33, FD&C YELLOW-6, GELATIN, GLYCERIN, LIGHT LIQUID PARAFFIN, POVIDONE, PURIFIED WATER, SODIUM CARBOXY METHYL CELLULOSE, SORBITOL SORBITAN SOLUTION, SOYA LECITHIN, TITANIUM DIOXIDE
    16. QUESTIONS OR COMMENTS? 1-888-333-9792
    17. PRINCIPLE DISPLAY PANEL

Bismuth Subsalicylate Product Label

The following document was submitted to the FDA by the labeler of this product Meijer Distribution, 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.

Drug Facts




Active Ingredient (In Each Softgel) Bismuth Subsalicylate 262 Mg




Purpose Upset Stomach Reliever And Anti-Diarrheal




Uses Relieves • Travelers' Diarrhea • Diarrhea • Upset Stomach Due To Overindulgence In Food And Drink, Including: • Heartburn • Indigestion • Nausea • Gas • Belching • Fullness




Warningsreye'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 • A Bleeding Problem • Bloody Or Black Stoo




Ask A Doctor Before Use If You Have • Fever • Mucus In The Stool




Ask A Doctor Or Pharmacist Before Use If You Aretaking Any Drug For • Anticoagulation (Thinning The Blood) • Diabetes • Gout • Arthritis




When Using This Producta Temporary, But Harmless, Darkening Of The Stool And/Or Tongue May Occur




Stop Use And Ask A Doctor If • Symptoms Get Worse Or Last More Than 2 Days • 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 Right Away.




Directions • Swallow With Water, Do Not Chew • Adults And Children 12 Years And Over: • 2 Softgels Every ½ Hour Or 4 Softgels Every Hour As Needed For Diarrhea • 2 Softgels Every ½ Hour To 1 Hour As Needed For Overindulgence (Upset Stomach, Heartburn, Indigestion, Nausea) • Do Not Exceed 8 Doses (16 Softgels) 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 Informationeach Softgel Contains:Salicylate 102 Mg • Very Low Sodium • Do Not Exceed 25°C




Inactive Ingredients Aerosil, Beeswax, D&C Red#33, Fd&C Yellow-6, Gelatin, Glycerin, Light Liquid Paraffin, Povidone, Purified Water, Sodium Carboxy Methyl Cellulose, Sorbitol Sorbitan Solution, Soya Lecithin, Titanium Dioxide




Questions Or Comments? 1-888-333-9792




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