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- Contains inactivated NDC Code(s)
NDC Code(s): 52904-903-04, 52904-903-05 - Packager: Select Corporation
- This is a repackaged label.
- Source NDC Code(s): 37000-477
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 15, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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- SPL UNCLASSIFIED SECTION
Drug Facts
- Active ingredient (in each tablet)
Bismuth subsalicylate 262 mg
- Purpose
Upset stomach reliever and Antidiarrheal
See AlsoWhat’s in This?: Pepto-Bismol - Uses
relieves
- travelers' 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 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
- anticoagulation (thinning the blood)
- diabetes
- gout
- arthritis
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.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
- Directions
- chew or dissolve in mouth
- adults & children 12 years & over:
2 tablets every 1/2 to 1 hour as needed - do not exceed 8 doses (16 tablets) 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 tablet contains:
- calcium 140 mg, magnesium 9 mg
- salicylate 101 mg
- very low sodium
- avoid excessive heat (over 104°F or 40°C)
- each tablet contains:
- Inactive ingredients
calcium carbonate, D&C Red No. 27 aluminum lake, flavor, magnesium stearate, mannitol, povidone, saccharin sodium, talc
- Questions?
1-800-717-3786
- SPL UNCLASSIFIED SECTION
PRODUCT REPACKAGED AND DISTRIBUTED WITH
PERMISSION OF MANUFACTURER BY:
Select Corporation Carrollton, TX 75007 - PRINCIPAL DISPLAY PANEL - 4 Tablet Pouch Blister Pack
Pepto-
Bismol™BISMUTH SUBSALICYLATE
UPSET STOMACH RELIEVER/ANTIDIARRHEAL5
SYMPTOM
Digestive Relief- heartburn
- indigestion
- nausea
- upset stomach
- diarrhea
4 Chewable Tablets
Multi-Pack
- INGREDIENTS AND APPEARANCE
PEPTO-BISMOL
bismuth subsalicylate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52904-903(NDC:37000-477) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength bismuth subsalicylate (UNII: 62TEY51RR1) (salicylic acid - UNII:O414PZ4LPZ) bismuth subsalicylate 262mg Inactive Ingredients Ingredient Name Strength calcium carbonate (UNII: H0G9379FGK) magnesium stearate (UNII: 70097M6I30) mannitol (UNII: 3OWL53L36A) povidone, unspecified (UNII: FZ989GH94E) D&C red no. 27 aluminum lake (UNII: ZK64F7XSTX) saccharin sodium (UNII: SB8ZUX40TY) talc (UNII: 7SEV7J4R1U) Product Characteristics Color PINK Score no score Shape ROUND Size 16mm Flavor WINTERGREEN Imprint Code Pepto;Bismol Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52904-903-04 1 in 1 BLISTER PACK 06/30/2004 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:52904-903-05 2 in 1 BLISTER PACK 06/30/2004 2 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part335 06/30/2004 Labeler -Select Corporation(053805599)
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Safety
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Related Resources
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More Info on this Drug
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View Labeling Archives for this drug
PEPTO-BISMOL- bismuth subsalicylate tablet
Number of versions: 1
| Published Date (What is this?) | Version | Files |
|---|---|---|
| Apr 18, 2022 | 1 (current) | download |
RxNorm
PEPTO-BISMOL- bismuth subsalicylate tablet
| RxCUI | RxNorm NAME | RxTTY | |
|---|---|---|---|
| 1 | 211151 | Pepto-Bismol 262 MG Chewable Tablet | PSN |
| 2 | 211151 | bismuth subsalicylate 262 MG Chewable Tablet [Pepto-bismol] | SBD |
| 3 | 211151 | Pepto-bismol 262 MG Chewable Tablet | SY |
| 4 | 211151 | Pepto-Bismol InstaCool 262 MG Chewable Tablet | SY |
| 5 | 211151 | Pepto-Bismol To-Go 262 MG Chewable Tablet | SY |
| 6 | 308761 | bismuth subsalicylate 262 MG Chewable Tablet | PSN |
| 7 | 308761 | bismuth subsalicylate 262 MG Chewable Tablet | SCD |
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NDC Codes
PEPTO-BISMOL- bismuth subsalicylate tablet
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
| NDC | |
|---|---|
| 1 | 52904-903-04 (inactivated) |
| 2 | 52904-903-05 (inactivated) |
