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1004- Major


Drug Facts

Active ingredient (in each tablet)

Pseudoephedrine HCl 30 mg


OTC - PURPOSE SECTION

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 SECTION

Do not use 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 - ASK DOCTOR SECTION

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 SECTION

When using this product do not exceed recommended dose.


OTC - STOP USE SECTION

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 SECTION

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


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.


OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.


Directions

adults & children 12 years & over2 tablets
children 6 to under 12 years1 tablets
children under 6 yearsdo not use
  • take every 4-6 hours
  • do not take more than 4 doses in 24 hours

Other information

  • Store between 15° - 30°C (59° - 86°F)
  • use by expiration date on package

INACTIVE INGREDIENT SECTION

calcium sulfate, carnauba wax, corn starch, croscarmellose sodium, FD&C red #40 lake, FD&C yellow #6 lake, gelatin, kaolin, lactose monohydrate, magnesium stearate, microcrystalline cellulose, shellac, silicon dioxide, stearic acid, sucrose, talc, titanium dioxide.


SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by: MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268 www.majorpharmaceuticals.com

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Sudafed®.


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAJOR ®

NDC 0904-6727-60

Non Drowsy SudoGest TM

Nasal Decongestant

Pseudoephedrine Hydrochloride 30mg

FOR PHARMACY USE ONLY.

NOT FOR RETAIL SALE.

Relieves Nasal and Sinus Congestion due to Colds or Hay Fever without drowsiness

Compare to the active ingredient in Sudafed® Sinus Congestion*

100 Tablets