Other
Drug Facts
Allergy alert: Contains salicylate. Do not take if you are
■ allergic to salicylates (including aspirin)
■ taking other salicylate products
Bismuth Subsalicylate Suspension
FDA Label NDC 76281-557
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aptapharma Inc. for the product Bismuth Subsalicylate Suspension (NDC 76281-557). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient
(in each 30 mL dose cup or 2 tablespoons)
Bismuth subsalicylate 525 mg
Otc - Purpose
Purposes
Bismuth subsalicylate .............. Upset stomach reliever
and antidiarrheal
Indications & Usage
Uses relieves ■ travelers' diarrhea ■ diarrhea
■ upset stomach due to overindulgence of food and drink
including: ■ heart burn ■ indigestion ■ nausea ■ gas
■ belching
Warnings
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 ■ an ulcer
■ a bleeding problem ■ black or bloody stool
Otc - Ask Doctor
Ask a doctor before use if you have
■ fever ■ mucus in 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
Slop 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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding, ask 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.
Dosage & Administration
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 Safety Information
Other information
■ each 30 mL dose cup contains: sodium 13 mg, salicylate 256 mg
■ protect from freezing ■ avoid excessive heat (over 104°F or 40°C)
■ Low sodium
Inactive Ingredient
Inactive ingredients benzoic acid, D&C red #22,
D&C red # 28, flavor, purified water, saccharin sodium,
salicylic acid, sodium salicylate, xantham gum
Otc - Questions
Questions? 1-877-798-5944
Principal Display Panel: Stomach Relief, Regular Strength
------------------------------------
AP SAFE® NDC 76281-557-28
*COMPARE TO
the active ingredient in
PEPTO-BISMOL™
Stomach
Relief
Bismuth Subsalicylate
Antidiarrheal/Upset Stomach Reliever
Regular Strength
5 Symptom Relief of:
● Nausea ● Heartburn ●Indigestion
● Upset stomach ● Diarrhea
12FL OZ (354 ml)
TAMPER EVIDENT: Do not use if imprinted
shrinkband is missing or broken
*This product is not manufactured or distributed by Procter & Gamble,
Inc., the distributor of Pepto-Bismol™.
Manufactured by: AptaPharma Inc.,
1533 Union Ave.
Pennsauken, NJ 081
LOT. EXP.
res
* Please review the disclaimer below.
