FDA.reportPublic FDA data

Propranolol Scopolamine

Manufacturer
TPS
Effective date
2014-10-15
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:19:37

Label at a glance#

ProductPropranolol Scopolamine
Active ingredientSCOPOLAMINE HYDROBROMIDE, PROPRANOLOL HYDROCHLORIDE
Label structure2 sections

Label contents#

Full prescribing information#

INSTRUCTIONS FOR USE SECTION

Take one tablet orally as directed by your physician as needed for symptoms of panic or anxiety.

Do not exceed two tablets per day.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TPS LLCTPS LLCTPS LLC

3524 DECATUR HWY FULTONDALE, AL 35068

877-608-4995 1-877-608-4995 BT9752747

Caution: Federal law prohibits transfer of this drug to any other person than patient for whom prescribed

Rx 263095 Jack Doe/Dr. Jane Doe MD

JOHN DOE

123 MAIN ST AUBURN, AL 12345

PROPRANOLOL SCOPOLAMINE TABLET TRITURATE

20 MG/0.25 MG

48 TABS Lot# Exp

Take 1 tablet sublingually or orally as directed by your physician as needed for symptoms of panic or anxiety.

Do not exceed 2 tablets per day

PH No refills authorized 10/8/2014

Pill bottle low res.jpg

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PROPRANOLOL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
SCOPOLAMINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fe8ea78e-e1a4-44bf-a6b2-42eed76976bbProduct name520250218
ba1babb5-1c2a-d9a8-0fd7-8f90d4f768cfProduct name220200609
a5696e6c-a559-4d6b-bb53-f324106f317cProduct name120140718
0f446d3d-c9e6-1844-b8e8-a836dc35e0deProduct name120140508
33a4b7b4-a3c1-3f95-a202-01166dd77c44Product name120140508
60519d27-227d-404a-38bc-37524c8b386bProduct name120140508
d5f30598-8f94-b083-f161-65d67f2ae12aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69267-201-062020-01-31C16284748780-19d75b9d0-bd97-f424-e053-dadaa90a57ce0579a12e-690b-3fa0-e054-00144ff88e88
69267-201-122020-01-31C16284748780-19d75b9d0-bd97-f424-e053-dadaa90a57ce0579a12e-690b-3fa0-e054-00144ff88e88
69267-201-242020-01-31C16284748780-19d75b9d0-bd97-f424-e053-dadaa90a57ce0579a12e-690b-3fa0-e054-00144ff88e88
69267-201-482020-01-31C16284748780-19d75b9d0-bd97-f424-e053-dadaa90a57ce0579a12e-690b-3fa0-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69267-201-06Propranolol Scopolamine121.5 mg in 1 BOTTLE, PLASTICTABLET121.51
69267-201-12Propranolol Scopolamine243 mg in 1 BOTTLE, PLASTICTABLET2431
69267-201-24Propranolol Scopolamine486 mg in 1 BOTTLE, PLASTICTABLET4861
69267-201-48Propranolol Scopolamine972 mg in 1 BOTTLE, PLASTICTABLET9721

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69267-201PROPRANOLOL SCOPOLAMINE TABLET [TPS]1Legacy NDC, 4 package rows20141015_0579a12e-690b-3fa0-e054-00144ff88e88.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PROPRANOLOL HYDROCHLORIDEACTIVE INGREDIENTF8A3652H1V1
SCOPOLAMINE HYDROBROMIDEACTIVE INGREDIENT451IFR0GXB1
PROPRANOLOLACTIVE MOIETY9Y8NXQ24VQ1
SCOPOLAMINEACTIVE MOIETYDL48G20X8X1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69267-20169267-201-06, 69267-201-12, 69267-201-24, 69267-201-48

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
SCOPOLAMINE HYDROBROMIDE451IFR0GXBACTIB
PROPRANOLOL HYDROCHLORIDEF8A3652H1VACTIB

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
0579a12e-690c-3fa0-e054-00144ff88e880579a12e-690b-3fa0-e054-00144ff88e882014-10-15Exact identifier
spl id: 0579a12e-690c-3fa0-e054-00144ff88e88
spl set id: 0579a12e-690b-3fa0-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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