FDA Label for Chewable Stomach Relief
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH CHEWABLE TABLET)
- PURPOSE
- USES
- REYE'S SYNDROME
- ALLERGY ALERT
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Chewable Stomach Relief 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.
Other
Drug Facts
Active Ingredient (In Each Chewable Tablet)
Bismuth subsalicylate 262 mg
Purpose
Antidiarrheal/ upset stomach reliever
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 or vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
Allergy Alert
Do not use if you are
• allergic to salicylate (including aspirin)• taking other salicylate products
Otc - Do Not Use
Do not use if you have
• an ulcer• a bleeding problem• bloody or black stool
Otc - Ask Doctor
Ask a doctor before use if you have
• fever• mucus in the stool
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking any drug for
• anticoagulation (thinning of the blood)• diabetes• gout• arthritis
Otc - When Using
When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur
Otc - Stop Use
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 breastfeeding, 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 immediately at 1-800-222-1222
Directions
• chew or dissolve tablets in mouth• adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed• do not exceed 8 doses (16 tablets) in 24 hours• use until diarrhea stops but not more than 2 days• drink plenty of clear fluids to help prevent dehydration caused by diarrhea• children under 12 years: ask a doctor
Other Information
• each tablet contains: salicylate 102 mg• Store at room temperature• avoid excessive heat• keep this carton for future reference on full labeling
Inactive Ingredients
flavor, magnesium stearate, microcrystalline cellulose, red #27 aluminum lake, sorbitol, sucralose.
Questions Or Comments?
1-866-467-2748
Principal Display Panel
Compare to active ingredient in Pepto-Bismol® Chewable Tablets*
Pink bismuth chewable tablets
Original flavor
bismuth subsalicylate 262mg/antidiarrheal
upset stomach, indigestion ,nausea, heartburn, diarrhea
30 CHEWABLE TABLETS
DO NOT USE IF INDIVIDUAL BLISTER COMPARTMENTS ARE TORN OR OPEN
*This product is not manufactured or distributed by Procter & Gamble Inc., the distributor of Pepto-Bismol®
DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.
3300 PUBLIX CORPORATE PARKWAY
LAKELAND, FL 33811
Publix.com
* Please review the disclaimer below.