Chest Congestion Relief, Guaifenesin Tablets, 400 mg

Manufacturer
Cardinal Health, Inc.
Effective date
2016-07-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:24:42

Label at a glance#

ProductGuaifenesin
Active ingredientGUAIFENESIN
Label structure13 sections

Indications and uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus helps make coughs more productive

Dosage and administration

Adults and children 12 years and over: take 1 tablet every 4 hours as needed Children 6 to under 12 years: take 1/2 tablet every 4 hours as needed Children under 6 years: consult a doctor Do not exceed 6 doses in a 24 hour period or as directed by a doctor.

Label contents#

Full prescribing information#

Active ingredient( per tablet)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 400mg

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
  • helps make coughs more productive

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

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

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • symptoms are accompanied by fever, rash or persistent headache
  • cough persists for more than 1 week or tends to recur

A persistent cough may be a sign of a serious condition.

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.

OVERDOSAGE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years and over: take 1 tablet every 4 hours as needed
  • Children 6 to under 12 years: take 1/2 tablet every 4 hours as needed
  • Children under 6 years: consult a doctor

Do not exceed 6 doses in a 24 hour period or as directed by a doctor.

Other information

HOW SUPPLIED SECTION

store at 15°-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, stearic acid, sodium starch glycolate.

Questions or comments?

OTC - QUESTIONS SECTION

1-888-341-9214

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Guaifenesin 400mg 50ct carton labelGuaifenesin 400mg 50ct carton labelGuaifenesin 400mg 50ct bottle labelGuaifenesin 400mg 50ct bottle labelGuaifenesin 400mg 50ct cartonGuaifenesin 400mg 50ct cartonGuaifenesin 400mg 50ct bottleGuaifenesin 400mg 50ct bottle

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0106-1EA - Each70000-010644943df5-737d-447b-a7e2-2777c2ce665712017-12-14

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-010670000-0106-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
256a3e24-0d6d-22c2-e054-00144ff88e88256a3e24-0d6c-22c2-e054-00144ff88e882016-07-15WarningsExact identifier
spl id: 256a3e24-0d6d-22c2-e054-00144ff88e88
spl set id: 256a3e24-0d6c-22c2-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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