FDA Label for Bismuth Subsalicylate
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- USES
- REYE'S SYNDROME:
- ALLERGY ALERT: CONTAINS SALICYLATE. DO NOT TAKE IF YOU ARE
- DO NOT USE IF YOU HAVE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Bismuth Subsalicylate Product Label
The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy, 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.
Other
Drug Facts
Otc - Purpose
Active ingredient ( in each softgel) Purpose
Bismuth subsalicylate 262 mg ................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
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
- a bleeding problem
- bloody or black stool
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 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 or last more than 2 days
- ringing in the ears or loss of hearing occurs
- diarrhea lasts more than 2 days
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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 Information
- each softgel contains: salicylate 102.33 mg
- very low sodium
- do not exceed 25°C
Inactive Ingredients
aerosil, beeswax, FD&C Red#33, FD&C Yellow#6, gelatin, glycerin, light liquid paraffin, purified water, soya lecithin, sodium carboxy methyl cellulose, sorbitol solution, titanium dioxide
Questions Or Comments?
1-888-333-9792
Principal Display Panel
Stomach Relief
BISMUTH SUBSALICYLATE 262 mg
Upset stomach reliever/Antidiarrheal
Soothing relief for 5 symptoms:
• Heartburn
• Indigestion
• Upset stomach
• Nausea
• Diarrhea
12 SOFTGELS
* Please review the disclaimer below.