Peptic Relief

Manufacturer
P & L Development, LLC
Effective date
2019-04-09
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-02 00:26:19

Label at a glance#

ProductPeptic Relief Maximum Strength
Active ingredientBISMUTH SUBSALICYLATE
Label structure15 sections

Indications and uses

relieves • upset stomach • heartburn • indigestion • diarrhea • nausea

Dosage and administration

shake well before use -for accurate dosing, use dose cup -adults and children 12 years and over: -1 dose (2 tablespoons or 30 ml) every hour as needed do not exceed 4 doses (8 tablespoons or 120 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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Bismuth Subsalicylate 525 mg

Purpose

OTC - PURPOSE SECTION

upset stomach
reliever/antidiarrheal

Uses

INDICATIONS & USAGE SECTION

relieves • upset stomach • heartburn
• indigestion • diarrhea • nausea

Warnings

WARNINGS SECTION

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: • taking other salicylate products
• allergic to salicylates (including aspirin)

Do not use if you have

OTC - DO NOT USE SECTION

an ulcer • a bleeding problem • bloody or black stool

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

fever • mucus in stool

Ask a doctor or pharmacist before use if you are taking any drug for

OTC - ASK DOCTOR/PHARMACIST SECTION

anticoagulation (thinning blood)
• diabetes • gout • arthritis

When using this product

OTC - WHEN USING SECTION

a temporary, but harmless,
darkening of the stool and/or tongue may occur

Stop use and ask a doctor if

OTC - STOP USE SECTION

symptoms get worse

(ringing in the ears or loss of hearing occurs)
(diarrhea lasts more than 2 days)

If pregnant or breast-feeding,

PREGNANCY SECTION

ask a health professional before use.

Keep this and all drugs out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, seek professional
assistance or contact a Poison Control Center
immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

shake well before use
-for accurate dosing, use dose cup
-adults and children 12 years and over:
-1 dose (2 tablespoons or 30 ml) every hour as needed
do not exceed 4 doses
(8 tablespoons or 120 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

SPL UNCLASSIFIED SECTION

each tablespoon contains: sodium 6 mg
• sugar free • low sodium • keep tightly closed
• avoid excessive heat (over 104˚F or 40˚C)
• protect from freezing.
Total salicylate per tablespoon...........................236 mg
Visit www.peptic-drug-facts.com

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzoic acid, flavor,
magnesium aluminum silicate, methyl cellulose, purified
water, red 22, red 28, saccharin sodium, salicylic acid,
sodium salicylate, sorbic acid

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

maximum strength

stomach relief

bismuth subsalicylate

upset stomach

heartburn

indigestion

diarrhea

nausea

compare to the active ingredients in

pepto bismol maximum strength

8fl oz (237 ml)

image of label
image of label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BISMUTH SUBSALICYLATEACTIVE INGREDIENT62TEY51RR11
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIM1
D&C RED NO. 22INACTIVE INGREDIENT1678RKX8RT1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NH1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NC1
METHYLCELLULOSE (100 CPS)INACTIVE INGREDIENT4GFU244C4J1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY1
SALICYLIC ACIDINACTIVE INGREDIENTO414PZ4LPZ1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989B1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49580-002449580-0024-8

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 109 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSOLUTION / ORAL100 mgExact identifier — unii candidate
23 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCCREAM / TOPICAL3 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCPOWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
17 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET / BUCCAL0.4 mgExact identifier — unii candidate
34 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCCAPSULE / ORAL60 mgExact identifier — unii candidate
17 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYCAPSULE / ORAL24 mgExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYINJECTION / INTRAVENOUS22 mgExact identifier — unii candidate
34 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHCAPSULE / ORAL1 mgExact identifier — unii candidate
11 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSOLUTION / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
34 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BAEROSOL, FOAM / TOPICAL6 mgExact identifier — unii candidate
19 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET / ORAL43 mgExact identifier — unii candidate
34 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHAEROSOL / TOPICALNAExact identifier — unii candidate
11 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BSOLUTION/ DROPS / OPHTHALMIC0.2 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYLIQUID / ORAL3 mgExact identifier — unii candidate
34 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCSUSPENSION / ORAL5000 mg/5mlExact identifier — unii candidate
17 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSOLUTION / RECTAL665 mgExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET, FOR SUSPENSION / ORAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET, FILM COATED / ORAL5 mgExact identifier — unii candidate
19 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCTABLET, EXTENDED RELEASE / ORAL70 mgExact identifier — unii candidate
17 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET / SUBLINGUAL0.16 mgExact identifier — unii candidate
19 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET / RECTAL0.6 mgExact identifier — unii candidate
34 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMINJECTION / INTRAVENOUS5 %w/vExact identifier — unii candidate
23 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCSHAMPOO / TOPICAL1.25 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BSOLUTION / OPHTHALMIC0.2 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMAEROSOL, FOAM / TOPICAL1 mgExact identifier — unii candidate
23 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSUPPOSITORY / VAGINAL2 mgExact identifier — unii candidate
23 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMCONCENTRATE / ORAL12.5 mg/5mlExact identifier — unii candidate
23 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMAEROSOL, FOAM / VAGINAL0.1 %w/wExact identifier — unii candidate
23 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMLOTION / TOPICAL0.2 %w/wExact identifier — unii candidate
23 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYGRANULE, FOR SOLUTION / ORAL5.5 mg/120mlExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYWAFER / ORAL8 mgExact identifier — unii candidate
34 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSUSPENSION / RECTAL0.1 %w/wExact identifier — unii candidate
23 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSOLUTION / IRRIGATION0.02 %w/vExact identifier — unii candidate
23 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHCAPSULE, DELAYED RELEASE / ORAL1 mgExact identifier — unii candidate
11 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET / ORAL10 mgExact identifier — unii candidate
19 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BLOTION / TOPICAL4 mgExact identifier — unii candidate
19 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCOINTMENT / VAGINAL231 mgExact identifier — unii candidate
17 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSYRUP / ORAL20 mgExact identifier — unii candidate
23 equally ranked IID candidates
D&C RED NO. 22D&C RED NO. 221678RKX8RTCAPSULE / ORAL0.02 mgExact identifier — unii candidate
5 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHSOAP / TOPICALNAExact identifier — unii candidate
11 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSUSPENSION / ORAL5000 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYOINTMENT / DENTALNAExact identifier — unii candidate
34 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BEMULSION / OPHTHALMIC1 mgExact identifier — unii candidate
19 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCTABLET / ORAL60 mgExact identifier — unii candidate
17 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHPOWDER, FOR SUSPENSION / ORAL0.7 mg/5mlExact identifier — unii candidate
11 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHTABLET / ORALNAExact identifier — unii candidate
11 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BOINTMENT / TOPICAL0.1 %w/wExact identifier — unii candidate
19 equally ranked IID candidates
D&C RED NO. 22D&C RED NO. 221678RKX8RTTABLET, COATED / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCCONCENTRATE / ORAL410 mg/5mlExact identifier — unii candidate
17 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCPASTE, DENTIFRICE / DENTAL0.4 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
17 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYCONCENTRATE / ORAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
D&C RED NO. 22D&C RED NO. 221678RKX8RTSUSPENSION / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMCREAM / VAGINAL10 mgExact identifier — unii candidate
23 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSYRUP / ORAL24 mgExact identifier — unii candidate
34 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSUSPENSION / ORAL15 mgExact identifier — unii candidate
23 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMELIXIR / ORAL90 mgExact identifier — unii candidate
23 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSOLUTION / TOPICAL0.1 %w/wExact identifier — unii candidate
23 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
11 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET, FILM COATED, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
19 equally ranked IID candidates

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b606950c-e034-433f-8fcf-2209293c2fba3673665d-dbcf-487d-af3f-ca262673c1232019-04-09WarningsExact identifier
spl id: b606950c-e034-433f-8fcf-2209293c2fba
spl set id: 3673665d-dbcf-487d-af3f-ca262673c123

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.