FDA Label for Leader Stomach Relief Original Strength
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- WARNINGS
- 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
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL
Leader Stomach Relief Original Strength Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health. 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
Antidiarrheal/upset stomach reliever
(total salicylate 102 mg per tablet)
Uses
relieves
▪ travelers’ diarrhea▪ diarrhea▪ upset stomach due to overindulgence in food and drink, including:▪ heartburn▪ indigestion▪ nausea▪ gas▪ 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
▪ bloody or black stool▪ 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 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.
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 older: 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: salicylate 102 mg▪ Do not use if individual blister compartments are torn or open▪ Store at room temperature 59°-86°F
Inactive Ingredients
flavor, magnesium stearate, microcrystalline cellulose, red #27 aluminum lake, sorbitol, sucralose
Questions?
1-800-719-9260
Principal Display Panel
LEADER
NDC 37205-720-65
Compare to Pepto-Bismol® active ingredient*
Pink Bismuth
Chewable Tablets
Bismuth Subsalicylate 262 mg
Original Flavor
Provides Soothing Relief for:
• Indigestion• Upset Stomach• Nausea• Diarrhea• Heartburn
SATISFACTION GUARANTEED
30 CHEWABLE TABLETS
All Leader® Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.
Distributed By: Cardinal Health
Dublin, Ohio 43017
CIN 2572691
*This product is not manufactured or distributed by Procter & Gamble Inc., the distributor of PEPTO-BISMOL®.
* Please review the disclaimer below.