Indications and uses
relieves: heartburn indigestion upset stomach nausea diarrhea (Also relieves traveler's diarrhea and gas, belching, and fullness due to overindulgence with food and drink.)
Pink Bismuth (Bismuth Subsalicylate Oral Suspension)
- Manufacturer
- Pharmaceutical Associates, Inc.
- Effective date
- 2020-02-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:41:17
Label at a glance#
ProductPink Bismuth
Active ingredientBISMUTH SUBSALICYLATE
Label structure11 sections
Dosage and administration
shake well before use. adults and children 12 years and over: 1 dose (2 Tbsp or 30 mL) every 1/2 to 1 hour as needed do not exceed 8 doses (16 Tbsp or 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.
Storage and handling
each Tbsp (15 mL) contains: sodium 5 mg low sodium sugar free salicylate 145 mg may not meet USP requirements for pH pink colored, peppermint flavored liquid supplied in the following oral dosage form: NDC 0121-4803-30 (unit dose cups of 30 mL). store at 20° to 25°C (68° to 77°F). Protect from freezing.
Contacts and useful links#
Websitewww.paipharma.com
www.paipharma.com
www.paipharma.comLabel contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active Ingredient (in each 15 mL tablespoon)
Bismuth subsalicylate 262 mg
Purposes
upset stomach reliever and antidiarrheal
Uses
relieves:
- heartburn
- indigestion
- upset stomach
- nausea
- diarrhea
(Also relieves traveler's diarrhea and gas, belching, and fullness due to overindulgence with food and drink.)
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
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking any drug for
- anticoagulation (thinning the blood)
- diabetes
- gout
- arthritis
OTC - WHEN USING SECTION
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
- ringing in the ears or loss of hearing occurs
- diarrhea lasts more than 2 days
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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.
- adults and children 12 years and over: 1 dose (2 Tbsp or 30 mL) every 1/2 to 1 hour as needed
- do not exceed 8 doses (16 Tbsp or 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 Tbsp (15 mL) contains: sodium 5 mg
- low sodium
- sugar free
- salicylate 145 mg
- may not meet USP requirements for pH
- pink colored, peppermint flavored liquid supplied in the following oral dosage form: NDC 0121-4803-30 (unit dose cups of 30 mL).
- store at 20° to 25°C (68° to 77°F). Protect from freezing.
Inactive ingredients
D&C Red No. 22, D&C Red No. 28, methyl salicylate, peppermint flavor, potassium sorbate, purified water, salicylic acid, sodium benzoate, sodium saccharin, sodium salicylate, veegum and xanthan gum.
Questions or comments?
Call 1-800-845-8210
SPL UNCLASSIFIED SECTION
Pharmaceutical
Associates, Inc.
Greenville, SC 29605
www.paipharma.com
R08/09
PRINCIPAL DISPLAY PANEL - Unit Dose Cup Label
Delivers
30 mL
NDC 0121-4803-30
P
INK
B
ISMUTH
(Bismuth Subsalicylate
Oral Suspension)
524 mg/30 mL
SHAKE WELL
FOR INSTITUTIONAL USE ONLY
PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605
SEE INSERT
A48033001
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0121-4803-30 | 2022-09-21 | C162847 | 48780-1 | 956f9ecf-bd0f-621f-e053-dbdaa90a74ad | Pink Bismuth (Bismuth Subsalicylate Oral Suspension) |
| 0121-4803-30 | 2022-01-28 | C162847 | 48780-1 | 956f9ecf-bd0f-621f-e053-dbdaa90a74ad | Pink Bismuth (Bismuth Subsalicylate Oral Suspension) |
| 0121-4803-30 | 2020-02-11 | C162847 | 48780-1 | 956f9ecf-bd0f-621f-e053-dbdaa90a74ad | Pink Bismuth (Bismuth Subsalicylate Oral Suspension) |
| 0121-4803-30 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-bd0f-621f-e053-dbdaa90a74ad | Pink Bismuth (Bismuth Subsalicylate Oral Suspension) |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Bismuth Subsalicylate | ACTIVE INGREDIENT | 62TEY51RR1 | 1 | |
| Bismuth Subsalicylate | ACTIVE MOIETY | 62TEY51RR1 | 1 |
Products#
Every source-derived product name is available through these pages.
- Pink Bismuth
- Bismuth Subsalicylate
- XANTHAN GUM
- DOCUSATE SODIUM/SODIUM BENZOATE
- SALICYLIC ACID
- PEPPERMINT OIL
- PEPPERMINT
- BISMUTH CATION
- METHYL SALICYLATE
- MAGNESIUM ALUMINUM SILICATE
- D&C RED NO. 22
- D&C RED NO. 28
- SACCHARIN SODIUM
- SACCHARIN
- POTASSIUM SORBATE
- SODIUM SALICYLATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0121-4803 | 0121-4803-30 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| e9358cc1-adcf-3b03-e053-2a95a90a11fb | 03512dbe-bcdd-41a0-9b6f-3a7809cebc8d | 2022-09-21 | Warnings | 03512dbe-bcdd-41a0-9b6f-3a7809cebc8d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.