HISTANAZ- pseudoephedrine hcl, pyrilamine maleate tablet

Histanaz by

Drug Labeling and Warnings

Histanaz by is a Otc medication manufactured, distributed, or labeled by Capital Pharmaceutical, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PURPOSE

Decongestant, Antihistamine

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.

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.

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

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

ACTIVE INGREDIENT

Pseudoephedrine HCL

Pyrilamine Maleate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HISTANAZ 
pseudoephedrine hcl, pyrilamine maleate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29978-129
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	60 mg
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL)	PYRILAMINE MALEATE	30 mg

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C YELLOW NO. 6 ALUMINUM LAKE (UNII: GYP6Z2JR6Q)
POLYVINYL ALCOHOL (UNII: 532B59J990)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TALC (UNII: 7SEV7J4R1U)
CARNAUBA WAX (UNII: R12CBM0EIZ)

Product Characteristics
Color	yellow	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	D129
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29978-129-10	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/08/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	09/08/2025

Labeler - Capital Pharmaceutical, LLC (831545541)