FDA.reportPublic FDA data

WONDERBELLY MULTI-SYMPTOM

Manufacturer
Ginger Health Company
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:56:18

Label at a glance#

ProductWONDERBELLY MULTI-SYMPTOM
Active ingredientBISMUTH SUBSALICYLATE
Label structure11 sections

Indications and uses

relieves travelers' diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas belching fullness

Dosage and administration

chew or crush tablets completely before swallowing. Do not swallow tablets whole. adults and children 12 years of age and over: for diarrhea: 2 tablets (1 dose) every 1/2 hour or 4 tablets (2 doses) every hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea): 2 tablets (1 dose) every 1/2 hour as needed do not exceed 8 doses (16 tablets) in 24 hours use until diarrhea stops but not more ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 262 mg

Purposes

OTC - PURPOSE SECTION

Upset stomach reliever and anttidiarrheal

Uses

INDICATIONS & USAGE SECTION

relieves

  • travelers' diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
  • heartburn
  • indigestion
  • nausea
  • gas
  • belching
  • fullness

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 vomitting 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

OTC - DO NOT USE SECTION

you have

  • an ulcer
  • a bleeding problem
  • bloody or black stool

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • fever
  • mucus in the stool

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking any drug for

  • anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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 breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a 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

  • chew or crush tablets completely before swallowing. Do not swallow tablets whole.
  • adults and children 12 years of age and over:
  • for diarrhea: 2 tablets (1 dose) every 1/2 hour or 4 tablets (2 doses) every hour as needed
  • for overindulgence (upset stomach, heartburn, indigestion, nausea): 2 tablets (1 dose) every 1/2 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 of age: ask a doctor
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Other information

OTHER SAFETY INFORMATION

  • each tablet contains: calcium 65 mg, salicylate 102 mg
  • avoid excessive heat (over 104°F or 40°C)
  • do not use if safety seal on carton printed with "SEALED FOR YOUR SAFETY" is torn or missing
  • read and keep outer carton for full warnings and directions

Inactive ingredients

INACTIVE INGREDIENT SECTION

calcium carbonate, corn starch, natural flavors, sucrose, vegetable magnesium stearate

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-512-551-9770

SPL UNCLASSIFIED SECTION

Distributed by:

Ginger Health Company

Austin, Texas 78702

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CLEAN MEDICINE

No Dyes, No Artificial Sweeteners, Non-GMO, No Talc, No Titanium Dioxide

WONDERBELLY

Multi-Symptom

Bismuth Subsalicylate 262 mg

Upset Stomach

Nausea

Indigestion

Diarrhea

Fullness

ORANGE 7 CRÈME

Flavor

48 Chewable Tablets

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308761bismuth subsalicylate 262 MG Chewable TabletPSN1
308761bismuth subsalicylate 262 MG Chewable TabletSCD1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82431-304-04WONDERBELLY MULTI-SYMPTOM4 in 1 POUCHTABLET, CHEWABLE41
82431-304-12WONDERBELLY MULTI-SYMPTOM12 in 1 BOTTLETABLET, CHEWABLE121
82431-304-12WONDERBELLY MULTI-SYMPTOM1 in 1 CARTONTABLET, CHEWABLE11
82431-304-40WONDERBELLY MULTI-SYMPTOM40 in 1 BOTTLETABLET, CHEWABLE401
82431-304-40WONDERBELLY MULTI-SYMPTOM1 in 1 CARTONTABLET, CHEWABLE11
82431-304-48WONDERBELLY MULTI-SYMPTOM1 in 1 CARTONTABLET, CHEWABLE11
82431-304-48WONDERBELLY MULTI-SYMPTOM48 in 1 BOTTLETABLET, CHEWABLE481

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82431-304WONDERBELLY MULTI-SYMPTOM (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [GINGER HEALTH COMPANY]17 package rows20250302_29bb35d4-11e3-ec6d-e063-6394a90ab412.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82431-30482431-304-48, 82431-304-40, 82431-304-12, 82431-304-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
STARCH, CORNO8232NY3SJIACT
MAGNESIUM STEARATE70097M6I30IACT
SUCROSEC151H8M554IACT
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB
CALCIUM CARBONATEH0G9379FGKIACT

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
29bb35d4-11e4-ec6d-e063-6394a90ab41229bb35d4-11e3-ec6d-e063-6394a90ab4122024-12-20WarningsExact identifier
spl id: 29bb35d4-11e4-ec6d-e063-6394a90ab412
spl set id: 29bb35d4-11e3-ec6d-e063-6394a90ab412

Reported adverse events (FAERS/openFDA)#

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