Indications and uses
relieves diarrhea travelers’ diarrhea upset stomach due to overindulgence in food and drink, including heartburn gas indigestion nausea fullness belching
Stomach Relief
- Manufacturer
- PAI Holdings, LLC | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma
- Effective date
- 2023-07-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:29:04
Label at a glance#
ProductStomach Relief
Active ingredientBISMUTH SUBSALICYLATE
Label structure9 sections
Dosage and administration
mL = milliliter shake well before using only use dose ready dosing cup provided. Do not use any other dosing device 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 unti...
Storage and handling
each 30 mL contains : potassium 8 mg, sodium 9 mg each 30 mL contains : salicylate 206 mg low sodium protect from freezing avoid excessive heat (over 104ºF or 40ºC) supplied in the following oral dosage forms NDC 0121-0910-30: 30 mL unit dose cup, in a tray of ten cups.
Contacts and useful links#
Websitewww.paipharma.com
www.paipharma.com
www.paipharma.comLabel contents#
Full prescribing information#
Active ingredient (in each 30 mL dose )
Bismuth subsalicylate 525 mg
Purpose
Upset stomach reliever/Antidiarrheal
Uses
relieves
- diarrhea
- travelers’ diarrhea
- upset stomach due to overindulgence in food and drink, including
- heartburn
- gas
- indigestion
- nausea
- fullness
- belching
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
- 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
- diabetes
- gout
- arthritis
- anticoagulation (thinning the blood)
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 childen.
In case of overdose, get medical help or contact a Posion Control Center (1-800-222-1222) right away.
Directions
- mL = milliliter
- shake well before using
- only use dose ready dosing cup provided. Do not use any other dosing device
- 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 stop but not more than 2 days
- children under 12 years of age: ask a doctor
- drink plenty of clear fluids to help prevent dehydration cause by diarrhea
Other information
- each 30 mL contains: potassium 8 mg, sodium 9 mg
- each 30 mL contains: salicylate 206 mg
- low sodium
- protect from freezing
- avoid excessive heat (over 104ºF or 40ºC)
- supplied in the following oral dosage forms
NDC 0121-0910-30: 30 mL unit dose cup, in a tray of ten cups.
Inactive ingredients
benzoic acid, D&C red #22, D&C red #28, flavor, glycerin, purified water, sucralose, xanthan gum
Questions or comments?
Call 1-800-845-8210.
PACKAGED BY:
Pharmaceutical Associates, Inc.
Greenville, SC 29605
R11/20
Principal Display Panel
Delivers 30 mL
NDC 0121-0910-30
Bismuth Subsalicylate
525 mg/30 mL
Upset stomach reliever/Antidiarrheal
Package Not Child-Resistant
Pkg by: Pharmaceutical Associates, Inc.
Greenville, SC 29605
SEE INSERT
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0121-0910-30 | ML - Milliliter | 0121-0910 | e78c47fb-2e3a-4101-bed2-b07f44e44633 | 1 | 2020-09-14 |
| 0121-0910-40 | ML - Milliliter | 0121-0910 | 50f66932-b743-4691-afc3-1ed8426dca83 | 1 | 2020-09-14 |
Products#
Every source-derived product name is available through these pages.
- Stomach Relief
- Bismuth subsalicylate
- BISMUTH CATION
- SALICYLIC ACID
- BENZOIC ACID
- D&C RED NO. 22
- D&C RED NO. 28
- GLYCERIN
- WATER
- SUCRALOSE
- XANTHAN GUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0121-0910 | 0121-0910-30, 0121-0910-40 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BISMUTH SUBSALICYLATE | 62TEY51RR1 | ACTIB |
| BENZOIC ACID | 8SKN0B0MIM | IACT |
| D&C RED NO. 22 | 1678RKX8RT | IACT |
| D&C RED NO. 28 | 767IP0Y5NH | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| WATER | 059QF0KO0R | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| bf4391f3-878b-46e1-ae72-9c03e9f605dd | dacfae86-ac70-4dff-8211-6c9a0596bee6 | 2023-07-07 | Warnings | bf4391f3-878b-46e1-ae72-9c03e9f605dd dacfae86-ac70-4dff-8211-6c9a0596bee6 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.