FDA.reportPublic FDA data

Mucus Relief Cold and Sinus

Manufacturer
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
Effective date
2022-10-24
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:50:34

Label at a glance#

ProductMucus Relief Cold and Sinus Maximum Strength
Active ingredientACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

temporarily relieves these common cold and flu symptoms: nasal congestion headache sinus congestion and pressure sore throat minor aches and pains temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Dosage and administration

do not exceed recommended dose (see overdose warning) do not take more than 6 doses in a 24-hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor mL= milliliter adults and children 12 years and older: 20 mL in dosing cup provided every 4 hours children under 12 years of age: do not use

Label contents#

Full prescribing information#

Active ingredients (in each 20 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg 

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer 

Expectorant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these common cold and flu symptoms:
    • nasal congestion
    • headache
    • sinus congestion and pressure
    • sore throat
    • minor aches and pains
  • temporarily reduces fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

WARNINGS SECTION

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 6 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday while using this product

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

Do not use

OTC - DO NOT USE SECTION

  • for children under 12 years of age
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • diabetes
  • liver disease
  • heart disease
  • thyroid disease
  • high blood pressure
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

 taking the blood thinning drug warfarin.

When using this product

OTC - WHEN USING SECTION

do not use more than directed.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • redness or swelling is present
  • nervousness, dizziness or sleeplessness occur
  • new symptoms occur
  • pain, nasal congestion or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • cough comes back, or occurs with 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

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not exceed recommended dose (see overdose warning)
  • do not take more than 6 doses in a 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • mL= milliliter
  • adults and children 12 years and older: 20 mL in dosing cup provided every 4 hours
  • children under 12 years of age: do not use

Other information

SPL UNCLASSIFIED SECTION

  • each 20 mL contains: sodium 12 mg
  • store at room temperature. Do not refrigerate

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydous citric acid, EDTA disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, trisodium citrate dihydrate, sorbitol, sucralose, xanthan gum

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ages 12 and over 

Maximum Strength

Fast-Acting

Mucus Relief

Cold & Sinus

Multi-Symptom Relief

Acetaminophen

Guaifenesin

Phenylephrine HCl

Pain reliever/fever reducer

Expectorant

Nasal decongestant

Compare to active ingredients in Mucinex® Fast-Max® Maximum Strength Cold & Sinus Liquid*

DISTRIBUTED BY DOLGENCORP, LLC

100 MISSION RIDGE, GOODLETTSVILLE, TN 37072

888-309-9030

FL OZ (mL)

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

 *This product is not manufactured or distributed by Reckitt Benckiser, distributor of Mucinex® Fast-Max® Maximum Strength Cold & Sinus Liquid.

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dollar General Maximum Strength Mucus Relief Cold and Sinus Liquid
Dollar General Maximum Strength Mucus Relief Cold and Sinus Liquid

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D3
GUAIFENESINACTIVE INGREDIENT495W7451VQ3
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJ3
ACETAMINOPHENACTIVE MOIETY362O9ITL9D3
GUAIFENESINACTIVE MOIETY495W7451VQ3
PHENYLEPHRINEACTIVE MOIETY1WS297W6MV3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA3
GLYCERININACTIVE INGREDIENTPDC6A3C0OX3
PROPYL GALLATEINACTIVE INGREDIENT8D4SNN7V923
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V33
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU3
SORBITOLINACTIVE INGREDIENT506T60A25R3
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD43
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95K3
WATERINACTIVE INGREDIENT059QF0KO0R3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE3

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55910-03355910-033-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
EDETATE DISODIUM7FLD91C86KIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
PROPYL GALLATE8D4SNN7V92IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT

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 10 · 545 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SORBITOLSORBITOL506T60A25RINJECTION / INTRAMUSCULARNAExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / INTRAMUSCULAR4000 mgExact identifier — unii candidate
81 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.4 mgExact identifier — unii candidate
77 equally ranked IID candidates
PROPYL GALLATEPROPYL GALLATE8D4SNN7V92CAPSULE / ORAL7 mgExact identifier — unii candidate
9 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / RECTAL0.01 %w/vExact identifier — unii candidate
37 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / DENTAL0.08 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEFILM, SOLUBLE / ORAL1 mgExact identifier — unii candidate
29 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / AURICULAR (OTIC)10 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, FILM COATED / ORAL0.08 mgExact identifier — unii candidate
29 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / RECTAL3315 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / TRANSDERMAL500 mgExact identifier — unii candidate
81 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / OPHTHALMIC4 mgExact identifier — unii candidate
77 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / ORAL2590 mgExact identifier — unii candidate
81 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATETRISODIUM CITRATE DIHYDRATEB22547B95KSOLUTION / INTRAVENOUS41 mgExact identifier — unii candidate
47 equally ranked IID candidates
PROPYL GALLATEPROPYL GALLATE8D4SNN7V92SUSPENSION, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
9 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / TOPICAL4886 mgExact identifier — unii candidate
81 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / ORAL0.5 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION, CONCENTRATE / ORAL300 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATETRISODIUM CITRATE DIHYDRATEB22547B95KSOLUTION / RECTAL773 mgExact identifier — unii candidate
47 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / RECTAL46.18 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATETRISODIUM CITRATE DIHYDRATEB22547B95KTABLET, FILM COATED, EXTENDED RELEASE / ORAL200 mgExact identifier — unii candidate
47 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUINJECTION, SOLUTION / INTRAMUSCULAR4.8 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRACARDIAC2 mgExact identifier — unii candidate
77 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCONCENTRATE / ORAL600 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPRAY / NASAL5 mgExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii candidate
35 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / PERINEURAL0.02 %w/vExact identifier — unii candidate
61 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATETRISODIUM CITRATE DIHYDRATEB22547B95KINJECTION, SOLUTION / INTRA-ARTICULAR25 mgExact identifier — unii candidate
47 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, SOLUTION / INTRAVENOUS772 mgExact identifier — unii candidate
61 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSHAMPOO / TOPICAL0.75 %w/wExact identifier — unii candidate
37 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATETRISODIUM CITRATE DIHYDRATEB22547B95KSYRUP / ORAL705 mgExact identifier — unii candidate
47 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii candidate
44 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATETRISODIUM CITRATE DIHYDRATEB22547B95KGRANULE, FOR SUSPENSION / ORAL4950 mgExact identifier — unii candidate
47 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / RECTAL406 mgExact identifier — unii candidate
35 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATETRISODIUM CITRATE DIHYDRATEB22547B95KINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS0.03 mgExact identifier — unii candidate
47 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSPRAY, METERED / NASAL4 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION/ DROPS / OPHTHALMIC0.13 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATETRISODIUM CITRATE DIHYDRATEB22547B95KSUSPENSION / RESPIRATORY (INHALATION)2 mgExact identifier — unii candidate
47 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE / ORAL26.3 mgExact identifier — unii candidate
37 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATETRISODIUM CITRATE DIHYDRATEB22547B95KINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS800 mgExact identifier — unii candidate
47 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4POWDER, FOR SOLUTION / ORAL414 mgExact identifier — unii candidate
22 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii candidate
77 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRA-ARTICULAR45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KEMULSION / OPHTHALMIC0.3 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
PROPYL GALLATEPROPYL GALLATE8D4SNN7V92TABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
9 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, DELAYED RELEASE / ORAL36 mgExact identifier — unii candidate
81 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDFILM / SUBLINGUAL0.07 mgExact identifier — unii candidate
37 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATETRISODIUM CITRATE DIHYDRATEB22547B95KSOLUTION / RESPIRATORY (INHALATION)24 mgExact identifier — unii candidate
47 equally ranked IID candidates
TRISODIUM CITRATE DIHYDRATETRISODIUM CITRATE DIHYDRATEB22547B95KSUSPENSION / ORAL5013 mgExact identifier — unii candidate
47 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLLOZENGE / TRANSMUCOSAL44 mgExact identifier — unii candidate
61 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
66e4807c-3e92-44d7-b586-d31b41b3d2a90184dff9-51bd-41cb-9928-330a4198caf52022-10-24WarningsExact identifier
spl id: 66e4807c-3e92-44d7-b586-d31b41b3d2a9
spl set id: 0184dff9-51bd-41cb-9928-330a4198caf5

Reported adverse events (FAERS/openFDA)#

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