FDA.reportPublic FDA data

Pepto-Bismol Chewable, TRAVEL BASIX

Manufacturer
Lil' Drug Store Products, Inc.
Effective date
2023-10-03
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-05-31 23:56:26

Label at a glance#

ProductPepto-Bismol
Active ingredientBISMUTH SUBSALICYLATE
Label structure13 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 dissolve in mouth adults and children 12 years and over: 2 tablets (1 dose) every 1/2 hour or 4 tablets (2 doses) every hour as needed for diarrhea 2 tablets (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) 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...

Storage and handling

each tablet contains: calcium 140 mg, magnesium 9 mg salicylate 101 mg low sodium avoid excessive heat (over 104°F or 40°C)

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 antidiarrheal

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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
  • bloody or black stool

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • fever
  • mucus in the stool

OTC - ASK DOCTOR/PHARMACIST SECTION

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

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

OTC - WHEN USING SECTION

When using this product 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 or last more than 2 days
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 days

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • chew or dissolve in mouth
  • adults and children 12 years and over: 2 tablets (1 dose) every 1/2 hour or 4 tablets (2 doses) every hour as needed for diarrhea
  • 2 tablets (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
  • 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

Directions

RECENT MAJOR CHANGES SECTION

  • chew or dissolve in mouth
  • adults and children 12 years and over: 2 tablets (1 dose) every 1/2 hour or 4 tablets (2 doses) every hour as needed for diarrhea
  • 2 tablets (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
  • 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

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 140 mg, magnesium 9 mg
  • salicylate 101 mg
  • low sodium
  • avoid excessive heat (over 104°F or 40°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

calcium carbonate, D&C Red No. 27 aluminum lake, flavor, magnesium stearate, mannitol, povidone, saccharin sodium, talc

Questions?

OTC - QUESTIONS SECTION

1-800-717-3786

SPL UNCLASSIFIED SECTION

PRODUCT REPACKAGED AND DISTRIBUTED
WITH PERMISSION OF MANUFACTURER BY:
Lil' Drug Store Products, Inc.,1201 Continental Place NE, Cedar Rapids, IA 52402

Pepto Bismol Chewables, 6ct Lil' Drug Store - PDP/Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 6 Tablet Cello Pack CartonPRINCIPAL DISPLAY PANEL - 6 Tablet Cello Pack CartonPepto-Bismol ®

Bismuth Subsalicylate Upset Stomach Reliever/Antidiarrheal

CHEWABLES

5 SYMPTOM

RELIEF NAUSEA,

HEARTBURN, INDIGESTION,

UPSET STOMACH, DIARRHEA

6 Chewable Tablets

[Lil' Drug Store ® logo]

Pepto Bismol ® Chewables, 4ct TRAVEL BASIX - PDP/Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pepto

Bismol ®

Bismuth Subsalicylate

Upset Stomach Reliever/Antidiarrheal

CHEWABLES

5 SYMPTOM

RELEIEF

NAUSEA

HEARTBURN

INDIGESTION

UPSET STOMACH

DIARRHEA

4

Chewable Tablets

[TRAVEL BASIX logo]

PDP/PackagePDP/Package

Pepto Bismol ® Chewables, 4ct CVP HEALTH - PDP/Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pepto

Bismol ®

Bismuth Subsalicylate

Upset Stomach Reliever/Antidiarrheal

CHEWABLES

5 SYMPTOM

RELEIEF

NAUSEA

HEARTBURN, INDIGESTION

UPSET STOMACH, DIARRHEA

4

Chewable Tablets

[CVP HEALTH logo]

PDP/PackagePDP/Package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308761bismuth subsalicylate 262 MG Chewable TabletPSN10
211151Pepto-Bismol 262 MG Chewable TabletPSN10
211151bismuth subsalicylate 262 MG Chewable Tablet [Pepto-bismol]SBD10
308761bismuth subsalicylate 262 MG Chewable TabletSCD10
211151Pepto-bismol 262 MG Chewable TabletSY10
211151Pepto-Bismol InstaCool 262 MG Chewable TabletSY10
211151Pepto-Bismol To-Go 262 MG Chewable TabletSY10

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
66715-6423-2Pepto-Bismol Chewable, TRAVEL BASIX2 in 1 POUCHTABLET, CHEWABLE210
66715-6423-2Pepto-Bismol Chewable, TRAVEL BASIX2 in 1 CARTONTABLET, CHEWABLE210
66715-6523-2Pepto-Bismol Chewable, CVP HEALTH2 in 1 POUCHTABLET, CHEWABLE210
66715-6523-2Pepto-Bismol Chewable, CVP HEALTH2 in 1 CARTONTABLET, CHEWABLE210
66715-9723-2Pepto-Bismol2 in 1 POUCHTABLET, CHEWABLE210
66715-9723-2Pepto-Bismol2 in 1 CARTONTABLET, CHEWABLE210
66715-9723-3Pepto-Bismol2 in 1 POUCHTABLET, CHEWABLE210
66715-9723-3Pepto-Bismol3 in 1 CARTONTABLET, CHEWABLE310

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-6423PEPTO-BISMOL (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE PEPTO-BISMOL CHEWABLE, CVP HEALTH (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE PEPTO-BISMOL CHEWABLE, TRAVEL BASIX (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [LIL' DRUG STORE PRODUCTS, INC.]10Current NDC, 2 package rows20231005_dd2f2205-34d1-4960-bf37-bb8d534cd0e1.zip
66715-6523PEPTO-BISMOL (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE PEPTO-BISMOL CHEWABLE, CVP HEALTH (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE PEPTO-BISMOL CHEWABLE, TRAVEL BASIX (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [LIL' DRUG STORE PRODUCTS, INC.]10Current NDC, 2 package rows20231005_dd2f2205-34d1-4960-bf37-bb8d534cd0e1.zip
66715-9723PEPTO-BISMOL (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE PEPTO-BISMOL CHEWABLE, CVP HEALTH (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE PEPTO-BISMOL CHEWABLE, TRAVEL BASIX (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [LIL' DRUG STORE PRODUCTS, INC.]10Current NDC, Legacy NDC, 4 package rows20231005_dd2f2205-34d1-4960-bf37-bb8d534cd0e1.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Bismuth subsalicylateACTIVE INGREDIENT62TEY51RR13
Bismuth cationACTIVE MOIETYZS9CD1I8YE3
aluminum oxideINACTIVE INGREDIENTLMI26O69333
calcium carbonateINACTIVE INGREDIENTH0G9379FGK3
D&C red no. 27INACTIVE INGREDIENT2LRS185U6K3
magnesium stearateINACTIVE INGREDIENT70097M6I303
mannitolINACTIVE INGREDIENT3OWL53L36A3
povidonesINACTIVE INGREDIENTFZ989GH94E3
saccharin sodiumINACTIVE INGREDIENTSB8ZUX40TY3
talcINACTIVE INGREDIENT7SEV7J4R1U3

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66715-972366715-9723-2, 66715-9723-3
66715-652366715-6523-2
66715-642366715-6423-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
MAGNESIUM STEARATE70097M6I30IACT
MANNITOL3OWL53L36AIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
TALC7SEV7J4R1UIACT
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB
CALCIUM CARBONATEH0G9379FGKIACT
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
MAGNESIUM STEARATE70097M6I30IACT
MANNITOL3OWL53L36AIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
TALC7SEV7J4R1UIACT
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB
CALCIUM CARBONATEH0G9379FGKIACT
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
MAGNESIUM STEARATE70097M6I30IACT
MANNITOL3OWL53L36AIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
TALC7SEV7J4R1UIACT
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB
CALCIUM CARBONATEH0G9379FGKIACT

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 1 · 56 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
talcTALC7SEV7J4R1UTABLET, CHEWABLE / ORAL202 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
D&C red no. 27D&C RED NO. 272LRS185U6KTABLET, CHEWABLE / ORAL7 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ATABLET, CHEWABLE / ORAL3726 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, CHEWABLE / ORAL202 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYTABLET, CHEWABLE / ORAL84 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ATABLET, CHEWABLE / ORAL3726 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ETABLET, CHEWABLE / ORAL48 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
D&C red no. 27D&C RED NO. 272LRS185U6KTABLET, CHEWABLE / ORAL7 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ETABLET, CHEWABLE / ORAL48 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
aluminum oxideALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route
7 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, CHEWABLE / ORAL202 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ATABLET, CHEWABLE / ORAL3726 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
aluminum oxideALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route
7 equally ranked IID candidates
calcium carbonateCALCIUM CARBONATEH0G9379FGKTABLET, CHEWABLE / ORAL1650 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ATABLET, CHEWABLE / ORAL3726 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
D&C red no. 27D&C RED NO. 272LRS185U6KTABLET, CHEWABLE / ORAL7 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYTABLET, CHEWABLE / ORAL84 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
aluminum oxideALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route
7 equally ranked IID candidates
calcium carbonateCALCIUM CARBONATEH0G9379FGKTABLET, CHEWABLE / ORAL1650 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
aluminum oxideALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route
7 equally ranked IID candidates
D&C red no. 27D&C RED NO. 272LRS185U6KTABLET, CHEWABLE / ORAL7 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, CHEWABLE / ORAL202 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
aluminum oxideALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route
7 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYTABLET, CHEWABLE / ORAL84 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
calcium carbonateCALCIUM CARBONATEH0G9379FGKTABLET, CHEWABLE / ORAL1650 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
D&C red no. 27D&C RED NO. 272LRS185U6KTABLET, CHEWABLE / ORAL7 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ATABLET, CHEWABLE / ORAL3726 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
calcium carbonateCALCIUM CARBONATEH0G9379FGKTABLET, CHEWABLE / ORAL1650 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
D&C red no. 27D&C RED NO. 272LRS185U6KTABLET, CHEWABLE / ORAL7 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
D&C red no. 27D&C RED NO. 272LRS185U6KTABLET, CHEWABLE / ORAL7 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYTABLET, CHEWABLE / ORAL84 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
aluminum oxideALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route
7 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ETABLET, CHEWABLE / ORAL48 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ATABLET, CHEWABLE / ORAL3726 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ETABLET, CHEWABLE / ORAL48 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
calcium carbonateCALCIUM CARBONATEH0G9379FGKTABLET, CHEWABLE / ORAL1650 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYTABLET, CHEWABLE / ORAL84 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
calcium carbonateCALCIUM CARBONATEH0G9379FGKTABLET, CHEWABLE / ORAL1650 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, CHEWABLE / ORAL202 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ETABLET, CHEWABLE / ORAL48 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, CHEWABLE / ORAL202 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
aluminum oxideALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route
7 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ETABLET, CHEWABLE / ORAL48 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, CHEWABLE / ORAL202 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ETABLET, CHEWABLE / ORAL48 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYTABLET, CHEWABLE / ORAL84 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
calcium carbonateCALCIUM CARBONATEH0G9379FGKTABLET, CHEWABLE / ORAL1650 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYTABLET, CHEWABLE / ORAL84 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ATABLET, CHEWABLE / ORAL3726 mgExact identifier — unii+route+dosage form
7 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
Pepto-Bismol Chewable, TRAVEL BASIXBISMUTH SUBSALICYLATELil' Drug Store Products, Inc.dd2f2205-34d1-4960-bf37-bb8d534cd0e12023-10-03WarningsExact identifier
ndc (package): 66715-9723-3
ndc (package): 66715-6423-2
ndc (package): 66715-6523-2
ndc (package): 66715-9723-2
ndc (product): 66715-9723
ndc (product): 66715-6423
ndc (product): 66715-6523
ndc11 (package): 66715972303
ndc11 (package): 66715972302
ndc11 (package): 66715642302
ndc11 (package): 66715652302
spl id: 06d6de24-fbde-ec5d-e063-6394a90a4fff
spl set id: dd2f2205-34d1-4960-bf37-bb8d534cd0e1

Reported adverse events (FAERS/openFDA)#

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