FDA Label for Pink Bismuth
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH 15 ML)
- PURPOSES
- 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 THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Pink Bismuth Product Label
The following document was submitted to the FDA by the labeler of this product We Care Distributor 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 15 Ml)
Bismuth subsalicylate 262 mg
Purposes
Upset stomach reliever/antidiarrheal
Uses
- relieves upset stomach, heartburn, indigestion, nausea, diarrhea
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 vomitting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrom, a rare but serious illness.
Allergy alert:Contains salicylates. Do not take if you are
- taking other salicylate products
- allergic to salicylates (including aspirin)
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, a sodium-restricted diet, a magnesium 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 This And All Drugs Out Of The Reach Of Children.
In case of accidental overdose, seek professional assistance or contact a Poison Control Center right away.
Directions
- Shake well before use
- Use pre-measured cup for accurate dosing. mL = mililiter
- Adults and children 12 years and over: 1 dose (30 mL) every 1/2 to 1 hour as needed
- Do not take more than 4 doses 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 15 mL contains: Sodium 24 mg, Sugar free, Magnesium 32 mg
- Salicylate 159 mg
- Keep tightly closed
- Avoid excessive heat (over 104°F or 40°C)
- protect from freezing
- store at room temperature
- TEMPER EVIDENT: DO NOT USE THIS PRODUCT IF PRINTED INNER CAP SEAL IS BROKEN OR MISSING
Inactive Ingredients
carboxymethylcellulose sodium, D&C red #3, FD&C red #40, flavor, glycerin, magnesium aluminum silicate, saccharin sodium, salicylic acid, sodium benzoate, sodium salicylate, sorbitol, water
Questions Or Comments?
1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com
Principal Display Panel
Compare to Original Pepto-Bismol® active ingredient
ORIGINAL STRENGTH
Stomach Relief
Upset Stomach Reliever/Antidiarrheal
Bismuth Subsalicylate 262 mg
Protective Coating Action
Soothing Relief for 5 Symptoms:
Heartburn
Indigestion
Upset Stomach
Nausea
Diarrhea
* Please review the disclaimer below.
