Guaifenesin

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each extended-release tablet)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin, USP 1200 mg

Purpose

OTC - PURPOSE SECTION

Expectorant

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

• for children under 12 years of age

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• cough accompanied by too much phlegm (mucus)

Stop use and ask a doctor if

OTC - STOP USE SECTION

• cough lasts more than 7 days, comes back, or occurs with 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 the timing of meals
• adults and children 12 years of age and over: 1 extended-release tablet every 12 hours. Do not exceed 2 extended-release tablets in 24 hours.
• children under 12 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

• store between 20-25°C (68-77°F)
• TAMPER EVIDENT: DO NOT USE IF CARTON IS OPEN OR IF PRINTED SEAL ON BLISTER IS BROKEN OR MISSING.

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, povidone.

Questions?

OTC - QUESTIONS SECTION

call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984.

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:
SAM'S WEST, INC.
BENTONVILLE, AR 72716

PRINCIPAL DISPLAY PANEL - 1200 mg Tablet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Maximum Strength Mucinex^®
active ingredient*

NDC 68196-996-56

Member's Mark_™

Maximum Strength

Mucus Relief

Guaifenesin Extended-Release
Tablets, 1200 mg
Expectorant

• Relieves chest congestion
• Thins and loosens mucus

12
HOUR

56
Extended-
Release
Tablets

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Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

• Guaifenesin Extended Release
• Guaifenesin
• hypromellose, unspecified
• magnesium stearate
• silicon dioxide
• povidone, unspecified
• FD&C BLUE NO. 2

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

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Orange Book products#

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

Observed Orange Book product history#

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Product history page 1 of 3 · 86 observed states.

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Reported adverse events (FAERS/openFDA)#

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