Sinus Congestion PE

Major Pharmaceuticals

Major 44-542

FULL PRESCRIBING INFORMATION: CONTENTS*

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

FULL PRESCRIBING INFORMATION

Active ingredients (in each immediate release tablet)

Guaifenesin 400 mg
Phenylephrine HCl 10 mg

Purpose

Expectorant
Nasal decongestant

Sinus Congestion PE Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageway of bothersome mucus and make coughs more productive
• temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
• promotes nasal and/or sinus drainage
• 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

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• difficulty urinating due to an enlarged prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• cough accompanied by too much phlegm (mucus)

When using this product

do not exceed recommended dosage.

Stop use and ask a doctor if

•  you get nervous, dizzy or sleepless
• cough comes back or worsens
• symptoms do not improve within 7 days, come back or occur with fever, rash or persistent headache

These could be signs of a serious condition.

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 right away.

Directions

• adults and children 12 years of age and older: take 1 tablet every 4 hours, with a full glass of water, while symptoms persist. Do not exceed 6 tablets in 24 hours.
• children under 12 years of age: do not use

Sinus Congestion PE Other information

• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• see end flap for expiration date and lot number 

Inactive ingredients

hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid

Principal Display Panel

MAJOR®

NDC 0904-5792-52

MucusRelief
Sinus Guaifenesin 400 mg  Phenylephrine HCl 10 mg

Expectorant/Nasal Decongestant

• Alleviates Chest Congestion
• Relieves Nasal/Sinus Congestion
• Does Not Contain Pseudoephedrine

60 Tablets

Immediate Release

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

50844        REV0612C54211

Distributed by
Major Pharmaceuticals
31778 Enterprise Drive Livonia, MI 48150 USA
Re-order No. 006475        Rev. 05/13    M-17