Pseudoephedrine Hydrochloride Tablet, Film Coated
FDA Label NDC 0904-7409

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Pseudoephedrine Hydrochloride (NDC 0904-7409). 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, active ingredient (in each tablet), purpose, uses, otc - do not use, ask a doctor before use if you have, otc - when using, 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

Drug Facts

Distributed by:

MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
(800) 616-2471
www.majorpharmaceuticals.com

Active Ingredient (In Each Tablet)

Pseudoephedrine HCl, USP 120 mg

Purpose

Nasal decongestant

Uses

  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • temporarily relieves sinus congestion and pressure

Otc - Do Not Use

Do not useif 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.

Ask A Doctor Before Use If You Have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

Otc - When Using

When using this product do not exceed recommended dosage

Stop Use And Ask A Doctor If

  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or occur with a fever

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. (1-800-222-1222)

Directions

adults and children 12 years and over
  • take 1 tablet every 12 hours
  • do not take more than 2 tablets in 24 hours
children under 12 yearsdo not use this product in children under 12 years of age

Other Information

  • store at 59° to 77° F in a dry place. Protect from light
  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Inactive Ingredients

castor oil, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, titanium dioxide

Questions?

call 1-800-406-7984

Principal Display Panel - 120 Mg Tablet Blister Pack Carton

MAJOR ®

NDC 0904-7409-15

Compare to the active 

ingredient of Sudafed ® Sinus

Congestion 12-Hour**

Maximum Strength 

Pseudoephedrine Hydrochloride

12 Hour Extended-Release Tablets, USP

120 mg

Long-Acting Nasal Decongestant

Relieves Sinus Pressure and Congestion

Non-Drowsy

10 Coated Tablets** 120 mg each

**Capsule-shaped Tablets

Actual Size

Principal Display Panel (120 mg Tablet Blister Pack Carton)

Principal Display Panel (120 mg Tablet Blister Pack Carton)


* Please review the disclaimer below.