FDA Label for Histanaz
View Indications, Usage & Precautions
- DESCRIPTION
- INDICATIONS & USAGE
- OTHER SAFETY INFORMATION
- OTC - PURPOSE
- OTC - ASK DOCTOR
- WARNINGS
- OTC - DO NOT USE
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- OVERDOSAGE
- OTC - ACTIVE INGREDIENT
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Histanaz Product Label
The following document was submitted to the FDA by the labeler of this product Capital Pharmaceutical, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Description
Active ingredients
(in each tablet)
Pseudoephedrine HCl 60 mg
Pyrilamine Maleate 30 mg
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
Otc - Active Ingredient
Pseudoephedrine HCL
Pyrilamine Maleate
Package Label.Principal Display Panel
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