Stahist Tp
FDA Label NDC 58407-010

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Magna Pharmaceuticals, Inc. for the product Stahist Tp (NDC 58407-010). 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 other, uses, warnings, do not use this product, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Uses

→ Warnings

→ Do Not Use This Product

→ Ask A Doctor Before Use If You Have

→ Otc - Ask Doctor/pharmacist

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Purpose

→ Active Ingredients

→ Directions

→ Inactive Ingredients

→ Questions Or Comments?

→ Other Information

→ Principal Display Panel

Other

Drug Facts

Uses

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

runny nose
sneezing
itching of the nose or throat
itchy, watery eyes
nasal congestion
reduces swelling of nasal passages

Warnings

Do not exceed recommended dosage.

Do Not Use This Product

If you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains MAOI, ask a doctor or pharmacist before taking this product.

Ask A Doctor Before Use If You Have

a breathing problem such as emphysema or chronic bronchitis
glaucoma
heart disease
high blood pressure
thyroid disease
diabetes melitus
difficulty in urination due to enlargement of the prostate gland

Otc - Ask Doctor/Pharmacist

Ask a doctor before use if you are taking sedatives or tranquilizers

When Using This Product

excitability may occur, especially in children
may cause drowsiness
alcohol, sedatives and tranquilizers may increase drowsiness effect
avoid alcoholic beverages
use caution when driving a motor vehicle or operating machinery

Stop Use And Ask A Doctor If

nervousness, dizziness or sleeplessness occur
cough or nasal congestion persists for more than
1 week, tends to recur or is accompanied by a fever, rash
or persistent headache. These could be signs 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 accidental overdose, seek professional help or contact a Poison Control Center immediately.

Purpose

Nasal Decongestant

Antihistamine

Active Ingredients

(in each tablet)
Phenylephrine HCl 10 mg ..................... Nasal Decongestant
Triprolidine HCl 2.5 mg .................................. Antihistamine

Directions

Do not exceed recommended dosage.

Adults and children 12 years of age and over:	1 tablet by mouth every 4 hours, not to exceed 4 tablets in 24 hours, or as directed by a doctor
Children 6 to under 12 years of age:	½ tablet by mouth every 4 hours, not to exceed 2 tablets in 24 hours, or as directed by a doctor
Children under 6 years of age	Consult a doctor