Indications and uses
relieves travelers' diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: heartburn gas indigestion nausea fullness belching
Digestive Relief
- Manufacturer
- Being Well
- Effective date
- 2022-10-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:52:00
Label at a glance#
ProductDigestive Relief Regular Strength
Active ingredientBISMUTH SUBSALICYLATE
Label structure9 sections
Dosage and administration
mL = milliliter shake well before using measure only with dosing cup provided. do not use any other dosng device keep dosing cup with product adults and children 12 years and over: 30 mL (1 dose) every 1/2 to 1 hour as needed do not exceed 8 doses (240 mL) in 24 hours use until diarrhea stops but not more than 2 days children under 12 years of age: ask a doctor drink plenty of clear fluids to help prevent dehydrat...
Storage and handling
each 30 mL contains: sodium 6 mg each 30 mL contains: salicylate 243 mg low sodium keep tightly closed protect from freezing avoid excessive heat (over 104ºF or 40ºC)
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each 30 mL)
Bismuth subsalicylate 525 mg
Purpose
Upset stomach reliever/Antidiarrheal
Uses
relieves
- travelers' diarrhea
- 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 ahould 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 right away. (1-800-222-1222)
Directions
- mL = milliliter
- shake well before using
- measure only with dosing cup provided. do not use any other dosng device
- keep dosing cup with product
- adults and children 12 years and over:
- 30 mL (1 dose) every 1/2 to 1 hour as needed
- do not exceed 8 doses (240 mL) in 24 hours
- use until diarrhea stops but not more than 2 days
- children under 12 years of age: ask a doctor
- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
Other information
- each 30 mL contains: sodium 6 mg
- each 30 mL contains: salicylate 243 mg
- low sodium
- keep tightly closed
- protect from freezing
- avoid excessive heat (over 104ºF or 40ºC)
Inactive ingredients
benzoic acid, D&C red #22, D&C red #28, flavor, magnesium aluminum silicate, methylcellulose, purified water, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid
Principal Display Panel
Compare to Pepto Bismol® active
5 Symptom Digestive Relief
Bismuth Subsalicylate 525 mg per 30 mL
Upset Stomach Reliever / Anti-Diarrheal
Relief of
Nausea
Heartburn
Indigestion
Upset Stomach
Diarrhea
FL OZ (mL)
*This product is not manufactured or distributed by The Procter & Gamble Company. Pepto-Bismol® is a registered trademark of The Procter & Gamble Company.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY: SAVE A LOT, LTD. ST. ANN, MO 63074
savealot.com
Package Label
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 46994-372-08 | 2022-10-10 | C162847 | 48780-1 | d6a99b39-364c-a426-e053-dadaa90af4c2 | Drug Facts |
| 46994-372-08 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-364c-a426-e053-dadaa90af4c2 | Drug Facts |
Products#
Every source-derived product name is available through these pages.
- Digestive Relief Regular Strength
- Bismuth subsalicylate
- BISMUTH CATION
- SALICYLIC ACID
- BENZOIC ACID
- D&C RED NO. 22
- D&C RED NO. 28
- MAGNESIUM ALUMINUM SILICATE
- WATER
- SACCHARIN SODIUM
- SODIUM SALICYLATE
- SORBIC ACID
- METHYLCELLULOSE (1500 CPS)
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 46994-372 | 46994-372-08 |
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 |
| MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | IACT |
| WATER | 059QF0KO0R | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SALICYLIC ACID | O414PZ4LPZ | IACT |
| SODIUM SALICYLATE | WIQ1H85SYP | IACT |
| SORBIC ACID | X045WJ989B | IACT |
| METHYLCELLULOSE (1500 CPS) | P0NTE48364 | 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 |
|---|---|---|---|---|---|---|
| 9b8ade31-231a-4e63-a936-f06126af2546 | 55ab4c4d-4d75-4370-abbf-13cc320975ba | 2022-10-10 | Warnings | 9b8ade31-231a-4e63-a936-f06126af2546 55ab4c4d-4d75-4370-abbf-13cc320975ba |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.