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Sinus Congestion PE

Dosage form
TABLET, FILM COATED
Labeler
Preferred Pharmaceuticals, Inc.
Label updated
2019-11-01
Retrieved
2026-09-07
Active ingredients
GUAIFENESIN · PHENYLEPHRINE HYDROCHLORIDE
View original label and images on DailyMed ↗
Active ingredients (in each immediate-release tablet)

Guaifenesin 400 mg
Phenylephrine HCl 10 mg

Purpose

Expectorant
Nasal decongestant

Uses
  • •helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways 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 you have

  • •heart disease
  • •high blood pressure
  • •thyroid disease
  • •diabetes
  • •difficulty in urination due to enlargement of the 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

  • •nervousness, dizziness, or sleeplessness occur
  • •symptoms do not improve within 7 days or are accompanied by fever
  • •cough persists more than 7 days, tends to recur, or is accompanied by a 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 (1-800-222-1222) right away.

Directions
  • •take with a full glass of water
  • •adults and children 12 years and over: 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
  • •children under 12 years: do not use
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 0904-5792-46

Mucus Relief
Sinus

Guaifenesin 400 mg /
Phenylephrine HCl 10 mg

Expectorant / Nasal Decongestant

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

30 Tablets

Immediate
Release

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

50844      REV0118E54201
Distributed by MAJOR PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152 USA
REV. 02/18   M-17    Re-order No. 006474

[Image in the official label — see DailyMed source]

DailyMed Set ID: 31257238-a0b0-4f2c-98ea-c24b8a6dc30a · Version 4
NDC: 68788-0845