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.

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202

PRINCIPAL DISPLAY PANEL - 14 Tablet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO the active ingredient of
MAXIMUM STRENGTH Mucinex^® *See back panel

NDC 30142-962-14

Kroger_®

OUR PHARMACIST RECOMMENDED

Maximum Strength
Mucus Relief
ER-Max
Guaifenesin 1200 mg
Extended-Release
Tablets,
EXPECTORANT

• Relieves Chest Congestion
• Thins & Loosens Mucus

actual
size

12
HOUR

14 EXTENDED-RELEASE
TABLETS

DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Dashboard NDC Coverage#

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
• FD&C BLUE NO. 2
• POVIDONE, UNSPECIFIED

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#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

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 3 · 86 observed states.

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.