Sudogest PE

Major Pharmaceuticals

Major 44-453

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each caplet)
• Purpose
• Sudogest PE Uses
• Warnings
  • Do not use
  • Ask a doctor before use if you have
  • When using this product
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children.
• Directions
• Sudogest PE Other information
• Inactive ingredients
• Questions
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient (in each caplet)

Phenylephrine HCl 10 mg

Purpose

Nasal decongestant

Sudogest PE Uses

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

• temporarily relieves sinus congestion and pressure

Warnings

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.

Ask a doctor before use if you have

• diabetes

• heart disease

• high blood pressure

• thyroid disease

• trouble urinating due to an enlarged prostate gland

When using this product

do not exceed recommended dose.

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur

• symptoms do not improve within 7 days or occur with fever

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.

• children under 12 years: do not use this product in children under 12 years of age

Sudogest PE Other information

• store at controlled room temperature 15°-30°C (59°-86°F)

• see end flap for expiration date and lot number

Inactive ingredients

croscarmellose sodium, dextrose monohydrate, dicalcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silica gel, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide

Questions

1-800-426-9391

Principal Display Panel

Non-Drowsy

NDC 0904-5733-73

MAJOR®

*Compare to the active ingredient in Sudafed PE® Congestion

SUDOGEST™ PE
Phenylephrine HCl, 10 mg each
NASAL DECONGESTANT

Does not contain Pseudoephedrine

• Nasal & Sinus Congestion
• Sinus Pressure

1 Pill Per Dose

36 TABLETS
10 mg each

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed PE® Congestion
50844        REV0313H45307

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Distributed by
MAJOR PHARMACEUTICALS
31778 Enterprise Drive
Livonia, MI 48150 USA                                 M-17
Rev. 08/13                  Re-order No. 100112