Guaifenesin Extended Release

Label at a glance#

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-719-9260

Websitewww.perrigo.comwww.perrigo.com

Label contents#

Full prescribing information#

Active ingredient (in each extended-release tablet)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 600 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.

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. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

• do not crush, chew, or break 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: one or two tablets every 12 hours. Do not exceed 4 tablets in 24 hours.
• children under 12 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

• do not use if printed seal under cap is broken or missing
• store between 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

compressible sugar, copovidone, hydroxyethyl cellulose, silicon dioxide, zinc stearate

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Distributed by Perrigo^®

Allegan, MI 49010

www.perrigo.com

49878 RT F3

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

• Guaifenesin Extended Release Extended Release
• Guaifenesin
• COPOVIDONE K25-31
• SILICON DIOXIDE
• ZINC STEARATE
• HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 78 matching rows.

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 · 81 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.