Tussin Mucus and Chest Congestion

Manufacturer
QUALITY CHOICE (Chain Drug Marketing Association)
Effective date
2023-05-11
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:31:30

Label at a glance#

ProductTussin Mucus and Chest Congestion Adult
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 ingredients (in each 10 mL)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 200 mg

Purposes

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

anhydrous citric acid, caramel, 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 1-248-449-9300 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Adult

Tussin

Mucus + Chest Congestion

Guaifenesin 200 mg  Expectorant

Relieves:

Mucus

Chest congestion

For ages 12 & Over

Alcohol Free

Non-Drowsy

Original Formula

 FL OZ (mL)

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

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER THE CAP IS BROKEN OR MISSING.

Distributed by: C.D.M.A., Inc.©

43157 W. Nine Mile

Novi, Ml 48376-0995

www.qualitychoice.com

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QUALITY CHOICE Mucus and Chest Congestion
QUALITY CHOICE Mucus and Chest Congestion

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-859-042023-05-11C16284748780-1f386c64a-358f-0266-e053-dadaa90a7c1aDrug Facts
63868-859-082023-05-11C16284748780-1f386c64a-358f-0266-e053-dadaa90a7c1aDrug Facts
63868-859-042023-01-30C16284748780-1f386c64a-358f-0266-e053-dadaa90a7c1aDrug Facts
63868-859-082023-01-30C16284748780-1f386c64a-358f-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-859-04ML - Milliliter63868-8590b4d9c7d-2990-4639-9805-b0b220dfd51312018-03-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
GUAIFENESINACTIVE INGREDIENT495W7451VQ2
GUAIFENESINACTIVE MOIETY495W7451VQ2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL2
CARAMELINACTIVE INGREDIENTT9D99G2B1R2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6S2
MENTHOL, UNSPECIFIED FORMINACTIVE INGREDIENTL7T10EIP3A2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU2
SUCROSEINACTIVE INGREDIENTC151H8M5542
WATERINACTIVE INGREDIENT059QF0KO0R2

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
63868-85963868-859-08, 63868-859-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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 6 · 317 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSPONGE / TOPICALNAExact identifier — unii candidate
35 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION / SUBCUTANEOUS47.75 mgExact identifier — unii candidate
48 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, SOLUTION / SUBCUTANEOUS25 mgExact identifier — unii candidate
61 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYAEROSOL, METERED / RESPIRATORY (INHALATION)0.05 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSPRAY / NASAL5 mgExact identifier — unii candidate
61 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / OPHTHALMIC0.09 %w/vExact identifier — unii candidate
61 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLAEROSOL / TOPICAL0.08 %w/wExact identifier — unii candidate
61 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, EFFERVESCENT / ORAL840 mgExact identifier — unii candidate
61 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSOLUTION / ORAL665 mgExact identifier — unii candidate
34 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / DENTALNAExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL48 mgExact identifier — unii candidate
61 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii candidate
35 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCAPSULE / ORAL131 mgExact identifier — unii candidate
61 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET / SUBLINGUAL7 mgExact identifier — unii candidate
34 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET, FILM COATED / ORAL2 mgExact identifier — unii candidate
34 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
HIGH FRUCTOSE CORN SYRUPHIGH FRUCTOSE CORN SYRUPXY6UN3QB6SSUSPENSION / ORAL20000 mgExact identifier — unii candidate
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUINJECTION / INTRAVENOUS864 mgExact identifier — unii candidate
35 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYELIXIR / ORAL15 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, SOLUTION / INTRAVENOUS772 mgExact identifier — unii candidate
61 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYGRANULE, FOR SOLUTION / ORAL5.5 mg/120mlExact identifier — unii candidate
34 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORMMENTHOLL7T10EIP3ASOLUTION / ORAL3 mgExact identifier — unii candidate
24 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPASTE, DENTIFRICE / DENTAL0.5 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLLOZENGE / TRANSMUCOSAL44 mgExact identifier — unii candidate
61 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, CHEWABLE / ORAL7258 mgExact identifier — unii candidate
48 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORMMENTHOLL7T10EIP3AINHALANT / NASAL32 mgExact identifier — unii candidate
24 equally ranked IID candidates
SUCROSESUCROSEC151H8M554POWDER, FOR SUSPENSION / ORAL40017 mgExact identifier — unii candidate
48 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAPOWDER, FOR SUSPENSION / ORAL3 mgExact identifier — unii candidate
28 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORMMENTHOLL7T10EIP3AJELLY / NASAL32.5 mgExact identifier — unii candidate
24 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CONCENTRATE / ORAL4800 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SOLUTION / RECTAL35.42 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORMMENTHOLL7T10EIP3ASOLUTION / DENTALNAExact identifier — unii candidate
24 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLPASTE / ORAL26 mgExact identifier — unii candidate
61 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, DELAYED RELEASE / ORAL295.33 mgExact identifier — unii candidate
48 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION/ DROPS / ORAL15 mgExact identifier — unii candidate
61 equally ranked IID candidates
SUCROSESUCROSEC151H8M554POWDER / ORAL27768 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SUSPENSION/ DROPS / ORAL3750 mgExact identifier — unii candidate
48 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUFILM / BUCCAL1 mgExact identifier — unii candidate
35 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SUSPENSION / ORAL48209 mgExact identifier — unii candidate
48 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYCONCENTRATE / ORAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, EMULSION / INTRAVENOUS970 mgExact identifier — unii candidate
48 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / ORAL3900 mgExact identifier — unii candidate
61 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SYRUP / ORAL46400 mgExact identifier — unii candidate
48 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYINJECTION / INTRAVENOUS22 mgExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCONCENTRATE / ORAL20 mgExact identifier — unii candidate
35 equally ranked IID candidates

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
0e18c005-6df2-459d-88cb-2f4b93063b7abbfe7864-fdde-4d1b-bbbb-c567a99e65562023-05-11WarningsExact identifier
spl id: 0e18c005-6df2-459d-88cb-2f4b93063b7a
spl set id: bbfe7864-fdde-4d1b-bbbb-c567a99e6556

Reported adverse events (FAERS/openFDA)#

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