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  5. Label Information: Pseudoephedrine Hydrochloride

FDA Label for Pseudoephedrine Hydrochloride

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH TABLET)
    3. PURPOSE
    4. USES
    5. OTC - DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. OTC - WHEN USING
    8. STOP USE AND ASK A DOCTOR IF
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS?
    15. PRINCIPAL DISPLAY PANEL - 120 MG TABLET BLISTER PACK CARTON

Pseudoephedrine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Major Pharmaceuticals. 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.

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 - nasal 01

PRINCIPAL DISPLAY PANEL - 120 mg Tablet Blister Pack Carton - nasal 01



* Please review the disclaimer below.