Active Ingredient (In Each 30 Ml Dose)
Bismuth subsalicylate 525 mg
Signature Care Suspension
FDA Label NDC 21130-182
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Safeway for the product Signature Care (NDC 21130-182). 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 active ingredient (in each 30 ml dose), purposes, 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Upset stomach reliever and antidiarrheal
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 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: Contains salicylate.Do not take if you are
▪ allergic to salicylates (including aspirin)▪ taking other salicylate products
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
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 or last more than 2 days▪ 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 at 1-800-222-1222.
Directions
▪ shake well before use▪ Only use dose cup provided▪ adults and children 12 years and over: 30 mL (1 dose) every 1/2 hour or 60 mL (2 doses) every hour as needed for diarrhea/traveler’s diarrhea.▪ 30 mL (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)▪ do not exceed 8 doses (240 mL) 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 30 mL contains: potassium 14 mg, sodium 10 mg▪ salicylate 260 mg▪ low sodium▪ sugar free▪ store at room temperature▪ protect from freezing▪ avoid excessive heat (over 104°F or 40°C)
Inactive Ingredients
carboxymethylcellulose sodium, D&C Red No. 22, D&C Red No. 28, flavor, gellan gum, microcrystalline cellulose, potassium hydroxide, potassium sorbate, purified water, salicylic acid, simethicone emulsion, sodium benzoate, sucralose, xanthan gum
Questions Or Comments?
1-866-467-2748
Do not use if imprinted shrink band is missing or broken.
Principal Display Panel
Sinature SELECT™
COMPARE TO the active ingredient in PEPTO-BISMOL®*
STOMACH RELIEF
REGULAR STRENGTH
ORIGINAL FLAVOR
BISMUTH SUBSALICYLATE 525 MG
Upset Stomach Reliever/Antidiarrheal
Relief of:
▪ Nausea, Heartburn, Indigestion, Upset Stomach, Diarrhea
DISTRIBUTED BY: BETTER LIVING BRANDS LLC
P.O. BOX 99
PLEASANTON, CA 94566-0009
‡1-888-723-3929
*This product is not manufactured or distributed by Procter & Gamble, distributor Pepto-Bismol®.
Package Label 354 mL
* Please review the disclaimer below.
