FDA Label for Chewable
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- 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
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
Chewable Product Label
The following document was submitted to the FDA by the labeler of this product Publix Super Markets 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 Tablet)
Bismuth subsalicylate 262 mg
Purpose
Upset stomach reliever/antidiarrheal
Uses
relieves
- travelers’ diarrhea
- diarrhea
- upset stomach due to overindulgence in food and drink, including:
- heartburn
- indigestion
- nausea
- gas
- belching
- fullness
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
- a bleeding problem
- bloody or black stool
Ask A Doctor Before Use If You Have
- fever
- mucus in the stool
- kidney stones
- a calcium-restricted diet
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
- 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. (1-800-222-1222)
Directions
- chew or dissolve tablets in mouth
- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
- adults and children 12 years and over: 2 tablets every ½ to 1 hour, or 4 tablets every hour as needed
- do not exceed 16 tablets in 24 hours
- use until diarrhea stops but not more than 2 days
- children under 12 years: ask a doctor
Other Information
- each tablet contains: calcium 265 mg and salicylate 99 mg
- store at 20°-25°C (68°-77°F)
Inactive Ingredients
calcium carbonate, D&C red #27 aluminum lake, FD&C blue #1 aluminum lake, flavor, magnesium stearate, mannitol, saccharin sodium
Principal Display Panel
STOMACH RELIEF
chewable
BISMUTH SUBSALICYLATE 262mg
ANTIDIARRHEAL
UPSET STOMACH RELIEVER
Soothing relief for:
heartburn
indigestion
upset stomach
nausea
diarrhea
ACTUAL SIZE
Compare to Active Ingredient in Pepto-Bismol® Chewable Tablets
* Please review the disclaimer below.