FDA.reportPublic FDA data

Rapidol Stomach Relief

Manufacturer
Pharmadel LLC
Effective date
2024-11-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:37:53

Label at a glance#

ProductRapidol Stomach Relief
Active ingredientBISMUTH SUBSALICYLATE
Label structure10 sections

Indications and uses

relieves travelers' diarrhea diarrhea upset stomach due to overindulgence of food and drink including: heart burn indigestion nausea gas belching

Dosage and administration

s hake well before use use dose cup or tablespoon (TBSP) adults and children 12 years and over: 1 dose (30 mL or 2 TBSP) every 1/2 to 1 hour or every hour as needed do not exceed 8 doses (240 mL or 16 TBSP) in 24 hours use until diarrhea stops but not more than 2 days drink plenty of clear fluids to help prevent dehydration caused by diarrhea children under 12 years: ask adoctor

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient & Purposes

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient
(in each 30 mL dose cup or 2 tablespoons)

Purposes
Bismuth subsalicylate 525 mg.................Upset stomach reliever and antidiarrhea

Uses

INDICATIONS & USAGE SECTION

relieves

  • travelers' diarrhea
  • diarrhea
  • upset stomach due to overindulgence of food and drink including:
  • heart burn
  • indigestion
  • nausea
  • gas
  • belching

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 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

OTC - DO NOT USE SECTION

  • an ulcer
  • a bleeding problem
  • black or bloody 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 of the 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.

Slop use and ask a doctor if

OTC - STOP USE SECTION

  • diarrhea lasts more than 2 days
  • symptoms get worse or last more than 2 days
  • ringing in the ears or loss of hearing occurs

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before use
  • use dose cup or tablespoon (TBSP)
  • adults and children 12 years and over: 1 dose (30 mL or 2 TBSP) every 1/2 to 1 hour or every hour as needed
  • do not exceed 8 doses (240 mL or 16 TBSP) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • children under 12 years: ask adoctor

Other information

OTHER SAFETY INFORMATION

  • each 30 mL dose contains: magnesium45 mg, sodium 13 mg, salicylate 256 mg
  • protect from freezing
  • avoid excessive heat (over 104ºF or 40ºC)
  • low sodium

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzoic acid, D&C red #22, D&C red #28, flavor, purified water, saccharin sodium, salicylic acid, sodium salicylate, xanthan gum

Questions?

OTC - QUESTIONS SECTION

1-866-359-3478 (9 AM - 5 PM EST) or pharmadel.com

Distributed by:

SPL UNCLASSIFIED SECTION

PHARMADEL LLC.

New Castle, DE 19720

Prinicpal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 55758-331-07

Rapidol Stomach Relief 8 FL OZ (237 mL)

Rapidol Stomach Relief PDPRapidol Stomach Relief PDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSN3
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCD3
308762bismuth subsalicylate 1.75 % Oral SuspensionSY3
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSY3
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSY3
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55758-331-07Rapidol Stomach Relief237 mL in 1 BOTTLELIQUID2373
55758-331-08Rapidol Stomach Relief240 mL in 1 BOTTLELIQUID2403

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55758-331RAPIDOL STOMACH RELIEF (BISMUTH SUBSALICYLATE) LIQUID [PHARMADEL LLC]3Current NDC, Legacy NDC, 2 package rows20241120_efba1aea-f468-4f63-e053-2995a90a545b.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55758-33155758-331-08, 55758-331-07

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
BENZOIC ACID8SKN0B0MIMIACT
D&C RED NO. 221678RKX8RTIACT
D&C RED NO. 28767IP0Y5NHIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SALICYLIC ACIDO414PZ4LPZIACT
SODIUM SALICYLATEWIQ1H85SYPIACT
XANTHAN GUMTTV12P4NEEIACT
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB

Source Document#

Source XML

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
Rapidol Stomach ReliefBISMUTH SUBSALICYLATEPharmadel LLCefba1aea-f468-4f63-e053-2995a90a545b2024-11-18WarningsExact identifier
ndc (package): 55758-331-07
ndc (package): 55758-331-08
ndc (product): 55758-331
ndc11 (package): 55758033107
ndc11 (package): 55758033108
spl id: 273676c9-a1f3-b2ca-e063-6294a90ad6e5
spl set id: efba1aea-f468-4f63-e053-2995a90a545b

Reported adverse events (FAERS/openFDA)#

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