FLANADOL PRONTO BISMUTH

Manufacturer
Jomex International Llc | Geri-Care Pharmaceuticals, Corp
Effective date
2016-07-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:25:24

Label at a glance#

ProductFLANADOL PRONTO BISMUTH
Active ingredientBISMUTH SUBSALICYLATE
Label structure11 sections

Storage and handling

•  each 15 mL tablespoonful contains: sodium 6 mg • salicylate 130 mg  • protect from freezing  • low sodium • sugar free • avoid excessive heat (over 104°F or 40°C) • visit www.info-xtra.com for health information • TAMPER EVIDENT: Do not use if imprinted neckband is missing or broken

Label contents#

Full prescribing information#

Active ingredient (in each 15mL Tablespoonful = TBSP)

OTC - ACTIVE INGREDIENT SECTION

Bismuth Subsalicylate 262 mg

Purposes

OTC - PURPOSE SECTION

Upset stomach reliever and antidiarrheal

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE SECTION

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

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 behaviour 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  • diarrhea lasts more than 2 days  • ringing in the ears or loss of hearing occurs

If pregnant or breast feeding, ask a health professional before use.

DOSAGE & ADMINISTRATION SECTION

Directions  • 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 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
  • children under 12 years: ask a doctor
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea

INACTIVE INGREDIENT SECTION

Inactive ingredients benzoic acid, flavor, magnesium aluminium silicate, methylcellulose, purified water, red 22, red 28, saccharin sodium, salicylic acid, simethicone emulsion, sodium salicylate, sorbic acid, xanthan gum

Other information

STORAGE AND HANDLING SECTION

• each 15 mL tablespoonful contains: sodium 6 mg

• salicylate 130 mg  • protect from freezing  • low sodium • sugar free

• avoid excessive heat (over 104°F or 40°C)

• visit www.info-xtra.com for health information

• TAMPER EVIDENT: Do not use if imprinted neckband is missing or broken

OTC - QUESTIONS SECTION

Questions? 1-866-838-7456

SPL UNCLASSIFIED SECTION

Regular Strength

Manufactured for:
Jomex Pharmaceuticals, LLC
Fairfax Station, VA 22039 USA

Manufactured by:
GCP Laboratories, Inc.
Gulfport, MS 39501

www.jomexusa.com
www.flanadolusa.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pronto1pronto1

SpanishSpanish

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69458-713-082024-12-23C16284748780-19d75b9d0-c4b7-f424-e053-dadaa90a57ceFLANADOL PRONTO BISMUTH
69458-713-082020-01-31C16284748780-19d75b9d0-c4b7-f424-e053-dadaa90a57ceFLANADOL PRONTO BISMUTH

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69458-71369458-713-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML · Source PDF

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
29f32457-23c4-d8a8-e063-6294a90a1e0dd0053c7f-1448-40f6-a7e7-279d2dff926a2024-12-23WarningsExact identifier
spl set id: d0053c7f-1448-40f6-a7e7-279d2dff926a

Reported adverse events (FAERS/openFDA)#

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