Otc - Active Ingredient
Active ingredient (in each tablet)
Bismuth subsalicylate 262 mg
5 Symptom Digestive Relief Tablet, Chewable
FDA Label NDC 11673-723
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Target Corporation for the product 5 Symptom Digestive Relief (NDC 11673-723). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Upset stomach reliever and antidiarrheal
Indications & Usage
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
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 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 (1-800-222-1222).
Dosage & Administration
Directions
- chew or dissolve in mouth
- adults and children 12 years and over:
- do not exceed 8 doses (16 tablets) 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
-2 tablets (1 dose) every ½ hour or 4 tablets (2 doses) every hour as needed for diarrhea
-2 tablets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
Storage And Handling
Other information
- each tablet contains: calcium 140 mg
- salicylate 101 mg
- low sodium
- avoid excessive heat (over 104°F or 40°C)
Inactive Ingredient
Inactive ingredients calcium carbonate, D&C red #27 lake, flavor, magnesium stearate, mannitol, povidone, saccharin sodium, talc
Otc - Questions
Questions or comments? Call 1-800-910-6874
Package Label.Principal Display Panel
Bismuth-48ct-ifc (Bismuth 48ct Ifc)
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