FDA Label for Bismuth Subsalicylate 262 Mg
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSES
- USES
- WARNINGS
- 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?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Bismuth Subsalicylate 262 Mg Product Label
The following document was submitted to the FDA by the labeler of this product Reliable 1 Laboratories Llc. 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
Allergy alert: Contains salicylates. Do not take if you are:
- allergic to salicylates (including aspirin)
- taking other salicylate products
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Pepto-Bismol®
Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580
Active Ingredient (In Each Tablet)
Bismuth subsalicylate 262 mg
Purposes
Anti-diarrheal / Upset stomach reliever
Uses
- controls diarrhea
- relieves upset stomach due to overindulgence in food or drink
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.
Otc - Do Not Use
Do not use
- if you have bloody or black stool
- if you have an ulcer or bleeding problem
Drug Facts continued on back of label
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 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 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
- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
- repeat dosage every 1/2 to 1 hour as needed
- do not take more than 8 doses in 24 hours
- use until diarrhea stops but not more than 2 days
- adults and children 12 years and over: 2 tablets
- children under 12 years: ask a doctor
Other Information
- each tablet contains: calcium 77 mg, salicylate 102 mg
- store at 15°-30°C (59°-86°F)
- protect from moisture
Inactive Ingredients
calcium carbonate, D&C red #27 (Al-lake), dextrose, flavor (cherry), magnesium stearate, maltodextrin, silicon dioxide, sorbitol
Questions Or Comments?
call 516-341-0666, 8:30 am- 4:30 pm ET, Monday-Friday
Package Label.Principal Display Panel
NDC 69618-029-03
Bismuth Subsalicylate
262 mg
UPSET STOMACH RELIEVER / ANTIDIARRHEAL
30 CHEWABLE TABLETS
*compare to Active Ingredients in Pepto-Bismol®
* Please review the disclaimer below.