FDA.reportPublic FDA data

Tussin Mucus and Chest Congestion

Manufacturer
ASSURED / DOLLAR TREE (Greenbrier International, Inc.)
Effective date
2023-01-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:40:03

Label at a glance#

ProductTussin Mucus and Chest Congestion
Active ingredientGUAIFENESIN
Label structure10 sections

Indications and uses

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Dosage and administration

do not take more than 6 doses in 24-hours period  measure only with dosing cup provided. Do not use any other dosing device. keep dosing cup with product mL = milliliter this adult product is not intended for use in children under 12 years of age adults and children 12 years and over: 10 to 20 mL every 4 hours children under 12 years: do not use

Storage and handling

each 10 mL contains: sodium 4 mg store between 20-25°C (68°-77°F). Do not refrigerate

Label contents#

Full prescribing information#

Active ingredient (in each 10 mL)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 200 mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Uses

INDICATIONS & USAGE SECTION

  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

Stop use and ask a doctor if

OTC - STOP USE SECTION

cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than 6 doses in 24-hours period 
  • measure only with dosing cup provided. Do not use any other dosing device.
  • keep dosing cup with product
  • mL = milliliter
  • this adult product is not intended for use in children under 12 years of age
  • adults and children 12 years and over: 10 to 20 mL every 4 hours
  • children under 12 years: do not use

Other information

STORAGE AND HANDLING SECTION

  • each 10 mL contains: sodium 4 mg
  • store between 20-25°C (68°-77°F). Do not refrigerate

Inactive ingredients

INACTIVE INGREDIENT SECTION

caramel, citric acid, FD&C red #40, flavor, glucose, glycerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate

Questions or comments?

OTC - QUESTIONS SECTION

 Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to active ingredient in Robitussin® Mucus + Chest Congestion Original* 

Tussin Mucus & Chest Congestion

Guaifenesin 200 mg - Expectorant

  • Alcohol Free
  • Non-Drowsy

Relieves Chest Congestion & Mucus

Ages 12+

FL OZ (mL)

*This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Robitussin® Mucus+Chest Congestion Original.

DISTRIBUTED BY

GREENBRIER INTERNATIONAL, INC.

500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
33992-038933992-0389-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
GUAIFENESIN495W7451VQACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
FD&C RED NO. 40WZB9127XOAIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
CARAMELT9D99G2B1RIACT
MENTHOLL7T10EIP3AIACT
DEXTROSEIY9XDZ35W2IACT

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
f9e1e31f-01c7-4d6e-9290-fa5739cc81dea95f8909-9bf1-4240-9fda-675fb0ddbc7d2023-01-19WarningsExact identifier
spl id: f9e1e31f-01c7-4d6e-9290-fa5739cc81de
spl set id: a95f8909-9bf1-4240-9fda-675fb0ddbc7d

Reported adverse events (FAERS/openFDA)#

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