Leader 44-542

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredients (in each immediate-release tablet)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 400 mg
Phenylephrine HCl 10 mg

Purpose

OTC - PURPOSE SECTION

Expectorant
Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

• 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

OTC - WHEN USING SECTION

 do not exceed recommended dosage.

Stop use and ask a doctor if

OTC - STOP USE SECTION

• 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70000-0141-1

LEADER♥_™

Mucus Relief PE
Sinus Congestion

Guaifenesin, 400 mg | Phenylephrine HCl, 10 mg
Expectorant | Nasal Decongestant

Clears Nasal / Sinus Congestion
Thins and Loosens Mucus
Immediate-Release

50 TABLETS

Actual Size

100% Money
Back Guarantee

Product Linked Resources#

DailyMed Product Concepts#

DailyMed Billing Units#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

• Mucus Relief PE Sinus Congestion
• Guaifenesin, Phenylephrine HCl
• GUAIFENESIN
• PHENYLEPHRINE HYDROCHLORIDE
• PHENYLEPHRINE
• HYPROMELLOSE, UNSPECIFIED
• MAGNESIUM STEARATE
• MALTODEXTRIN
• MICROCRYSTALLINE CELLULOSE
• POLYETHYLENE GLYCOL, UNSPECIFIED
• POVIDONE, UNSPECIFIED
• SILICON DIOXIDE
• SODIUM STARCH GLYCOLATE TYPE A POTATO
• STEARIC ACID

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.