FDA.reportPublic FDA data

Poly Hist Forte

Manufacturer
Poly Pharmaceuticals, Inc.
Effective date
2024-07-09
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:15:02

Label at a glance#

ProductPoly Hist Forte
Active ingredientDOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE
Label structure18 sections

Indications and uses

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

Dosage and administration

Do not exceed recommended dosage.  Adults and children 12 years of age and over  1 tablet every 4 hours, not to exceed 6 tablets in 24 hours.  Children 6 to 12 years of age:   1/2 tablet every 4 hours, not to exceed 3 tablets in 24 hours.  Children 6 years       of age and younger:        Consult a physician.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)

Doxylamine Succinate 10.5mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)

Phenylephrine HCl 10 mg            

Purpose

OTC - PURPOSE SECTION

Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

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

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

Do not use this product

OTC - DO NOT USE SECTION

  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

you are taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

  • excitability may occur, especially in children
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
  • 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
  • symptoms do not improve within 7 days or are accompanied by fever

If pregnant or breast-feeding,

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

Do not exceed recommended dosage.

 Adults and children 12 years of age and over 1 tablet every 4 hours, not to
exceed 6 tablets in 24 hours.
 Children 6 to 12 years of age:  1/2 tablet every 4 hours, not to
exceed 3 tablets in 24 hours.
 Children 6 years      
of age and younger:       		 Consult a physician.

Other information

SPL UNCLASSIFIED SECTION

Store at controlled room temperature between 15°-30°C (59°-86°F).

Supplied in a tight, light-resistant container with a child-resistant cap.

Poly Hist Forte Tablets are blue, caplet-shaped, scored tablets, debossed "Poly" bisect "216" on one side and plain on the other.

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Blue # 2, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.

Questions? Comments?

SPL UNCLASSIFIED SECTION

Call 1-800-882-1041

Manufactured for:

Poly Pharmaceuticals, Inc.

Huntsville, AL Rev. 4/16

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50991-626-01

POLY HIST FORTE ®

TABLETS

Nasal Decongestant • Antihistamine

NEW FORMULA

Each tablet contains:

Doxylamine Succinate . . . 10.5 mg

Phenylephrine HCl . . . . . . 10 mg

100 Tablets

backbacklabellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2172491doxylamine succinate 10.5 MG / phenylephrine HCl 10 MG Oral TabletPSN6
2172491doxylamine succinate 10.5 MG / phenylephrine hydrochloride 10 MG Oral TabletSCD6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DOXYLAMINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
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
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50991-626-01Poly Hist Forte100 in 1 BOTTLETABLET1006
50991-626-02Poly Hist Forte1 in 1 BLISTER PACKTABLET16
50991-626-02Poly Hist Forte12 in 1 CARTONTABLET126

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50991-626POLY HIST FORTE (DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [POLY PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 3 package rows20240711_8aa0015b-8fc1-7951-e053-2a95a90a8e72.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50991-626-01EA - Each50991-626a86a9901-8095-4bc6-a185-a73a0d76c1e012019-07-02

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50991-62650991-626-02, 50991-626-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C BLUE NO. 2L06K8R7DQKIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
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
Poly Hist ForteDOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDEPoly Pharmaceuticals, Inc.8aa0015b-8fc1-7951-e053-2a95a90a8e722024-07-09WarningsExact identifier
ndc (package): 50991-626-02
ndc (package): 50991-626-01
ndc (product): 50991-626
ndc11 (package): 50991062601
ndc11 (package): 50991062602
spl id: 1cda46d8-607e-048a-e063-6394a90a6d65
spl set id: 8aa0015b-8fc1-7951-e053-2a95a90a8e72

Reported adverse events (FAERS/openFDA)#

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