Guaifenesin D

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each extended-release tablet)	Purposes
Guaifenesin 600 mg	Expectorant
Pseudoephedrine HCl 60 mg	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:
  • common cold
  • hay fever
  • upper respiratory allergies
• temporarily restores freer breathing through the nose
• promotes nasal and/or sinus drainage
• temporarily relieves sinus congestion and pressure

Warnings

WARNINGS SECTION

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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble 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

OTC - WHEN USING SECTION

• do not use more than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

• you get nervous, dizzy, or sleepless
• symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness.

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.

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

Directions

DOSAGE & ADMINISTRATION SECTION

• do not crush, chew, or break extended-release tablet
• take with a full glass of water
• this product can be administered without regard for timing of meals
• adults and children 12 years and older: 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours
• children under 12 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

• Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing.
• store between 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

carbomer homopolymer, NF; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF

Questions?

OTC - QUESTIONS SECTION

call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984. You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017

PRINCIPAL DISPLAY PANEL - 36 Tablet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER_™

NDC 70000-0580-2

Mucus
Relief D
Guaifenesin, 600 mg
Pseudoephedrine Hydrochloride, 60 mg
Extended-Release Tablets
Expectorant | Nasal Decongestant

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

Actual Size

36
EXTENDED-RELEASE
TABLETS

COMPARE TO
MUCINEX^® D
active ingredients^†

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DailyMed Dashboard NDC Coverage#

DailyMed Billing Units#

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

• Guaifenesin D
• Guaifenesin and Pseudoephedrine Hydrochloride
• Guaifenesin
• Pseudoephedrine Hydrochloride
• PSEUDOEPHEDRINE
• CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
• HYPROMELLOSE, UNSPECIFIED
• MAGNESIUM STEARATE
• MICROCRYSTALLINE CELLULOSE

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

Orange Book application contexts#

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Orange Book application contexts page 1 of 1 · 1 matching rows.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 80 observed states.

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Reported adverse events (FAERS/openFDA)#

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