FDA.reportPublic FDA data

STAHIST TP

Manufacturer
Magna Pharmaceuticals, Inc.
Effective date
2023-10-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:56:36

Label at a glance#

ProductSTAHIST TP
Active ingredientTRIPROLIDINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes nasal congestion reduces swelling of nasal passages

Dosage and administration

Do not exceed recommended dosage. Adults and children 12 years of age and over: 1 tablet by mouth every 4 hours, not to exceed 4 tablets in 24 hours, or as directed by a doctor Children 6 to under 12 years of age: ½ tablet by mouth every 4 hours, not to exceed 2 tablets in 24 hours, or as directed by a doctor Children under 6 years of age Consult a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • nasal congestion
  • reduces swelling of nasal passages

Warnings

WARNINGS SECTION

Do not exceed recommended dosage.

Do not use this product

OTC - DO NOT USE SECTION

  • If you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes melitus
  • difficulty in urination due to enlargement of the prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor before use if you are taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • excitability may occur, especially in children
  • may cause drowsiness
  • alcohol, sedatives and tranquilizers may increase drowsiness effect
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness or sleeplessness occur
  • cough or nasal congestion persists for more than
    1 week, tends to recur or is accompanied by a fever, rash
    or persistent headache. These could be signs of a serious
    condition.
  • new symptoms occur

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 accidental overdose, seek professional help or contact a Poison Control Center immediately.

Purpose

OTC - PURPOSE SECTION

Nasal Decongestant

Antihistamine

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)
Phenylephrine HCl 10 mg ..................... Nasal Decongestant
Triprolidine HCl 2.5 mg .................................. Antihistamine

Directions

DOSAGE & ADMINISTRATION SECTION

Do not exceed recommended dosage.

Adults and children 12 years of age and over:1 tablet by mouth every 4 hours, not to exceed 4 tablets in 24 hours, or as directed by a doctor
Children 6 to under 12 years of age:½ tablet by mouth every 4 hours, not to exceed 2 tablets in 24 hours, or as directed by a doctor
Children under 6 years of ageConsult a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-888-206-5525

Other Information

SPL UNCLASSIFIED SECTION

Store at 15°-30° C (59°-86° F)
Tamper evident by foil seal under cap. Do not use if foil seal is
missing or broken.

Rev. 2/20

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Stahist TP Principal Display PanelStahist TP Principal Display Panel

Add image transcription here...

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1099659phenylephrine HCl 10 MG / triprolidine HCl 2.5 MG Oral TabletPSN4
1099659phenylephrine hydrochloride 10 MG / triprolidine hydrochloride 2.5 MG Oral TabletSCD4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58407-010-102025-01-30C16284748780-1c7ccaba7-1ea5-fd44-e053-dadaa90aa01bStahist TP
58407-010-102023-10-10C16284748780-1c7ccaba7-1ea5-fd44-e053-dadaa90aa01bStahist TP
58407-010-102023-07-28C16284748780-1c7ccaba7-1ea5-fd44-e053-dadaa90aa01bStahist TP
58407-010-102022-08-17C16284748780-1c7ccaba7-1ea5-fd44-e053-dadaa90aa01bStahist TP
58407-010-102021-07-23C16284748780-1c7ccaba7-1ea5-fd44-e053-dadaa90aa01bStahist TP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58407-010-10STAHIST TP100 in 1 BOTTLETABLET1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58407-010STAHIST TP (PHENYLEPHRINE HCL AND TRIPROLIDINE HCL) TABLET [MAGNA PHARMACEUTICALS, INC.]4Legacy NDC, 1 package rows20231011_a6b6f593-c35a-d821-e053-2a95a90ab09d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58407-010-10EA - Each58407-0107d8f7389-d6c4-448e-8b96-fb09bdf4e30f12020-07-13

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58407-01058407-010-10

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
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
TRIPROLIDINE HYDROCHLORIDEYAN7R5L890ACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB

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
0763e5e4-4182-da53-e063-6294a90aca3ea6b6f593-c35a-d821-e053-2a95a90ab09d2023-10-10WarningsExact identifier
spl id: 0763e5e4-4182-da53-e063-6294a90aca3e
spl set id: a6b6f593-c35a-d821-e053-2a95a90ab09d

Reported adverse events (FAERS/openFDA)#

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