Description
Active ingredients
(in each tablet)
Pseudoephedrine HCl 60 mg
Pyrilamine Maleate 30 mg
Histanaz Tablet
FDA Label NDC 29978-129
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Capital Pharmaceutical, Llc for the product Histanaz (NDC 29978-129). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding description, indications & usage, other safety information, otc - purpose, otc - ask doctor, warnings, otc - do not use, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
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
Decongestant, Antihistamine
Otc - Ask Doctor
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
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
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
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
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Inactive Ingredient
Carnauba Wax, Croscarmellose Sodium, FD&C Yellow #6 Aluminum Lake, Iron Oxide Yellow, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Silicon Dioxide, Talc, Titanium Dioxide.
Dosage & Administration
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. |
Overdosage
Label (Histanaz Capital)
Otc - Active Ingredient
Pseudoephedrine HCL
Pyrilamine Maleate
Package Label.Principal Display Panel
Label (Histanaz Capital)
* Please review the disclaimer below.
