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- NDC Code(s): 37000-438-04, 37000-438-08, 37000-438-12, 37000-438-16, view more
37000-438-24, 37000-438-32, 37000-438-34
- Packager: The Procter & Gamble Manufacturing Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 6, 2023
If you are a consumer or patient please visit this version.
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- SPL UNCLASSIFIED SECTION
Drug Facts
- Active ingredient (in each 30 mL dose)
Bismuth subsalicylate 525 mg
- Purpose
Upset stomach reliever and antidiarrheal
- Uses
relieves
- traveler's diarrhea
- diarrhea
- upset stomach due to overindulgence in food and drink, including:
- heartburn
- indigestion
- nausea
- gas
- belching
- fullness
- 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 ifyou 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 aretaking any drug for
- anticoagulation (thinning the blood)
- diabetes
- gout
- arthritis
When using this producta 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 children.In case of overdose, get medical help or contact a Poison Control Center right away.
- Directions
- shake well before use
- only use dose cup provided
- adults and children 12 years and over:
- 30 mL (1 dose) every ½ hour or 60 mL (2 doses) every hour as needed for diarrhea/traveler's diarrhea
- 30mL (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
- do not exceed 8 doses (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 30 mL dose contains:magnesium 3 mg, sodium 4 mg
- salicylate 261 mg
- low sodium
- protect from freezing
- avoid excessive heat (over 104°F or 40°C)
- TAMPER EVIDENT:Do not use if printed shrinkband is missing or broken.
- each 30 mL dose contains:magnesium 3 mg, sodium 4 mg
- Inactive ingredients
benzoic acid, D&C Red No. 22, D&C Red No. 28, flavor, gellan gum, magnesium aluminum silicate, methylcellulose, salicylic acid, sodium salicylate, sorbic acid, sucralose, water
- Questions?
1-800-717-3786
- SPL UNCLASSIFIED SECTION
DIST. BY PROCTER & GAMBLE,
CINCINNATI OH 45202 - PRINCIPAL DISPLAY PANEL - 354 mL Bottle Label
Pepto
Bismol®
Bismuth Subsalicylate
Upset Stomach Reliever/
Antidiarrheal
5 SYMPTOMRELIEF
NAUSEA
HEARTBURN
INDIGESTION
UPSET STOMACH
DIARRHEA12 FL OZ (354 mL)
- INGREDIENTS AND APPEARANCE
PEPTO-BISMOL
bismuth subsalicylate suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-438 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE 525mg in30mL Inactive Ingredients Ingredient Name Strength BENZOIC ACID (UNII: 8SKN0B0MIM) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) D&C RED NO. 22 (UNII: 1678RKX8RT) D&C RED NO. 28 (UNII: 767IP0Y5NH) SUCRALOSE (UNII: 96K6UQ3ZD4) SALICYLIC ACID (UNII: O414PZ4LPZ) SODIUM SALICYLATE (UNII: WIQ1H85SYP) SORBIC ACID (UNII: X045WJ989B) WATER (UNII: 059QF0KO0R) METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H) Product Characteristics Color pink Score Shape Size Flavor WINTERGREEN Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37000-438-04 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/01/2018 2 NDC:37000-438-08 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/01/2018 3 NDC:37000-438-12 354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/01/2018 4 NDC:37000-438-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/01/2018 5 NDC:37000-438-24 2 in 1 CELLO PACK 03/01/2018 5 354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 6 NDC:37000-438-32 2 in 1 CELLO PACK 03/01/2018 6 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 7 NDC:37000-438-34 100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M008 03/01/2018 Labeler -The Procter & Gamble Manufacturing Company(004238200)
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PEPTO-BISMOL- bismuth subsalicylate suspension
Number of versions: 9
| Published Date (What is this?) | Version | Files |
|---|---|---|
| Oct 9, 2023 | 10 (current) | download |
| Aug 29, 2023 | 9 | download |
| Aug 15, 2023 | 8 | download |
| Mar 31, 2023 | 7 | download |
| Aug 12, 2022 | 6 | download |
| Feb 16, 2021 | 5 | download |
| Dec 9, 2019 | 3 | download |
| Jun 12, 2018 | 2 | download |
| Mar 12, 2018 | 1 | download |
RxNorm
PEPTO-BISMOL- bismuth subsalicylate suspension
| RxCUI | RxNorm NAME | RxTTY | |
|---|---|---|---|
| 1 | 211176 | Pepto-Bismol 525 MG in 30 mL Oral Suspension | PSN |
| 2 | 211176 | bismuth subsalicylate 17.5 MG/ML Oral Suspension [Pepto-bismol] | SBD |
| 3 | 211176 | Pepto-bismol 17.5 MG/ML Oral Suspension | SY |
| 4 | 211176 | Pepto-bismol 262 MG per 15 ML Oral Suspension | SY |
| 5 | 211176 | Pepto-bismol 525 MG per 30 ML Oral Suspension | SY |
| 6 | 308762 | bismuth subsalicylate 525 MG in 30 mL Oral Suspension | PSN |
| 7 | 308762 | bismuth subsalicylate 17.5 MG/ML Oral Suspension | SCD |
| 8 | 308762 | bismuth subsalicylate 1.75 % Oral Suspension | SY |
| 9 | 308762 | bismuth subsalicylate 262 MG per 15 ML Oral Suspension | SY |
| 10 | 308762 | bismuth subsalicylate 524 MG per 30 ML Oral Suspension | SY |
| 11 | 308762 | bismuth subsalicylate 525 MG per 30 ML Oral Suspension | SY |
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NDC Codes
PEPTO-BISMOL- bismuth subsalicylate suspension
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
| NDC | |
|---|---|
| 1 | 37000-438-04 |
| 2 | 37000-438-08 |
| 3 | 37000-438-12 |
| 4 | 37000-438-16 |
| 5 | 37000-438-24 |
| 6 | 37000-438-32 |
| 7 | 37000-438-34 |
