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1215-Major


Drug Facts

Active ingredient (in each tablet)

Pseudoephedrine HCl 60 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

  • diabetes
  • heart disease
  • high blood pressure
  • thyroid disease
  • 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 and children 12 years and older: take 1 tablet every 4 to 6 hours. Do not take more than 4 tablets in 24 hours.
  • children under 12 years of age: do not use

Other information

  • store in a dry place at 15° – 30°C (59° – 86°F)
  • use by expiration date on package

INACTIVE INGREDIENT SECTION

croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, silica and stearic acid.


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


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAJOR

NDC 0904-6728-46

SudoGest TM

Nasal Decongestant

Pseudoephedrine Hydrochloride 60 mg

Relieves Nasal and Sinus Congestion due to Colds or Hay Fever Without Drowsiness

30 Tablets