Histanaz - Capital Pharmaceutical, LLC

Manufacturer
Capital Pharmaceutical, LLC
Effective date
2026-04-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:54:42

Label at a glance#

ProductHistanaz
Active ingredientPSEUDOEPHEDRINE HYDROCHLORIDE, PYRILAMINE MALEATE
Label structure14 sections

Label contents#

Full prescribing information#

DESCRIPTION SECTION

Active ingredients
(in each tablet)
Pseudoephedrine HCl 60 mg
Pyrilamine Maleate 30 mg

INDICATIONS & USAGE SECTION

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

  • nasal congestion
  • runny nose
  • itchy watery eyes
  • itching of the nose and throat

OTHER SAFETY INFORMATION

Questions? Comments?
Serious side effects may be reported to this number.
Call 1 (614) 638-4622

OTC - PURPOSE SECTION

Decongestant, Antihistamine

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • heart disease
  • thyroid disease
  • diabetes
  • trouble urinating due to enlargement of the prostate gland

WARNINGS SECTION

Warnings
Do not exceed recommended dosage.
May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery.

OTC - DO NOT USE SECTION

Do not use this product 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.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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 overdose, get medical help or contact a Poison Control Center right away.

INACTIVE INGREDIENT SECTION

FD&C Yellow #5, Magnesium Stearate, Microcrystalline Cellulose, Silicon Dioxide and Sodium Starch Glycolate.

DOSAGE & ADMINISTRATION SECTION

Directions:

Do not exceed recommended dosage.

Adults and Children
12 years of age and
over:
1 tablet every 6/8 hours.
Do not exceed 4 tablets in
24 hours.
Children 6-12 years
of age:
1/2 tablet every 6/8 hours.
Do not exceed 2 tablets in
24 hours.

OTC - ACTIVE INGREDIENT SECTION

Pseudoephedrine HCL

Pyrilamine Maleate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2727351pseudoephedrine HCl 60 MG / pyrilamine maleate 30 MG Oral TabletPSN2
2727351pseudoephedrine hydrochloride 60 MG / pyrilamine maleate 30 MG Oral TabletSCD2

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130329978129101GTIN-13: 0329978129101
EAN-13: 0329978129101
GTIN-12: 329978129101
UPC-A: 329978129101
GTIN storage (14 digits): 00329978129101
histanez.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29978-129-10Histanaz100 in 1 BOTTLETABLET1002

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
29978-12929978-129-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-09-11monthly-update2026-06-03 17:38:43

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
HistanazPSEUDOEPHEDRINE HCL, PYRILAMINE MALEATECapital Pharmaceutical, LLC3e87d0f3-f16c-5972-e063-6294a90acc8a2026-04-22WarningsExact identifier
ndc (package): 29978-129-10
ndc (product): 29978-129
ndc11 (package): 29978012910
spl id: 5013a487-2901-ef02-e063-6394a90a2902
spl set id: 3e87d0f3-f16c-5972-e063-6294a90acc8a

Reported adverse events (FAERS/openFDA)#

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