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#
Contacts and useful links#
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
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| PSEUDOEPHEDRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0329978129101 | GTIN-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 | Effective |
|---|---|---|---|
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| 0fdb98e2-b951-a1ce-5715-2b187ba500ef | Product name | 4 | 20170718 |
| e974e22d-8688-7d92-1e87-40c1079e170c | Product name | 3 | 20151125 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 30c51294-7ae9-8007-7de6-58222684a0be | Product name | 1 | 20140508 |
| 4f26f669-fc6c-40ef-9e26-1c7b2390ee66 | Product name | 1 | 20140508 |
| 70a83adc-6047-bbea-5a08-dfd304aa47d2 | Product name | 1 | 20140508 |
| 858ce051-9941-aafc-8c7c-44a8e0227463 | Product name | 1 | 20140508 |
| b893258d-0942-3d8a-3411-056ea0788ff5 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 29978-129-10 | Histanaz | 100 in 1 BOTTLE | TABLET | 100 | 2 |
Products#
Every source-derived product name is available through these pages.
- Histanaz
- Pseudoephedrine HCL, Pyrilamine Maleate
- MAGNESIUM STEARATE
- PSEUDOEPHEDRINE HYDROCHLORIDE
- PSEUDOEPHEDRINE
- CELLULOSE, MICROCRYSTALLINE
- PYRILAMINE MALEATE
- PYRILAMINE
- SILICON DIOXIDE
- SODIUM STARCH GLYCOLATE TYPE A
- FD&C YELLOW NO. 5
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 29978-129 | 29978-129-10 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| PSEUDOEPHEDRINE HYDROCHLORIDE | 6V9V2RYJ8N | ACTIB |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| PYRILAMINE MALEATE | R35D29L3ZA | ACTIB |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| SODIUM STARCH GLYCOLATE TYPE A | H8AV0SQX4D | IACT |
| FD&C YELLOW NO. 5 | I753WB2F1M | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 1 | 2025-09-11 | monthly-update | 2026-06-03 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Histanaz | PSEUDOEPHEDRINE HCL, PYRILAMINE MALEATE | Capital Pharmaceutical, LLC | 3e87d0f3-f16c-5972-e063-6294a90acc8a | 2026-04-22 | Warnings | 29978-129-10 29978-129 29978012910 5013a487-2901-ef02-e063-6394a90a2902 3e87d0f3-f16c-5972-e063-6294a90acc8a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
