Drug Facts Active Ingredient (In Each 30 Ml)
Bismuth subsalicylate 525 mg
Dr. Simi Stomach Relief Suspension
FDA Label NDC 85786-802
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Farmacias De Similares Tx Llc for the product Dr. Simi Stomach Relief (NDC 85786-802). 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 drug facts active ingredient (in each 30 ml), 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 taking any drug for, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Upset stomach reliever and antidiarrheal
Uses
relieves: ▪ diarrhea ▪ heart burn ▪ indigestion
▪ nausea ▪ upset stomach associated with these symptoms
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
▪ an ulcer
▪ a bleeding problem
▪ black or bloody stool
Ask A Doctor Before Use If You Have
▪ fever ▪ mucus in stool
Ask A Doctor Or Pharmacist Before Use If You Are Taking Any Drug For
▪ anticoagulation (thinning of 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
▪ diarrhea lasts more than 2 days
▪ symptoms get worse or last more than 2 days
▪ ringing in the ears or loss of hearing occurs
If Pregnant Or Breast Feeding,
ask 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
▪ shake well before use
▪ use dose cup or tablespoon (TBSP)
▪ adults and children 12 years and over: 1 dose (30 mL or 2 TBSP) every 1/2 to 1 hour as needed
▪ do not exceed 8 doses (240 mL or 16 TBSP) 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 dose cup contains: sodium 13 mg, salicylate 256 mg
▪ protect from freezing avoid excessive heat (over 104°F or 40C)
▪ low sodium
Inactive Ingredients
benzoic acid, D&C red #22, D&C red # 28, flavor, purified water, saccharin sodium, salicylic acid, sodium salicylate, xanthan gum
Questions Or Comments?
(855)-280-1079
Principal Display Panel
NDC 85786-802-12
DR. SIMI
Regular Strength
Stomach Relief
Bismuth Subsalicylate 525 mg
Antidiarrheal /Upset Stomach Reliever
Relieves:
▪ Upset Stomach ▪ Nausea ▪ Heartburn
▪ Indigestion ▪ Diarrhea
12 fl oz (354 mL)
TAMPER EVIDENT: Do not use if imprinted shrinkband is missing or broken
*Compare to the active ingredient in PEPTO-BISMOL™
*This product is not manufactured or distributed by Procter&Gamble the distributor of Pepto-Bismol ®
Distributed by:
FARMACIAS DE SIMILARES TX LLC.
800 Brazos St Ste 260, Austin, TX, 78701, USA
www.drsimi.com
* Please review the disclaimer below.
