Mucus Relief Cold, Flu, Sore Throat

Manufacturer
ASSURED / DOLLAR TREE (Greenbrier International, Inc.)
Effective date
2021-10-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:33:55

Label at a glance#

ProductMucus Relief Cold, Flu, Sore Throat Maximum Strength
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporarily relieves these common cold and flu symptoms: headache nasal congestion sore throat cough 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 take more than directed (see overdose warning) do not take more than 12 softgels  in any 24-hour period adults and children 12 years of age and older: take 2 softgels every 4 hours children under 12 years of age: do not use

Label contents#

Full prescribing information#

Active ingredients (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg 

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer 

Cough suppressant

Expectorant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these common cold and flu symptoms:
    • headache
    • nasal congestion
    • sore throat
    • cough
    • 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

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

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.

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

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

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

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

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 (1-800-222-1222) 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 take more than directed (see overdose warning)
  • do not take more than 12 softgels  in any 24-hour period
  • adults and children 12 years of age and older: take 2 softgels every 4 hours
  • children under 12 years of age: do not use

Other information

SPL UNCLASSIFIED SECTION

  • swallow whole; do not crush, chew, or dissolve
  • avoid excessive heat
  • store between 15-30ºC (59-86ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C red #40, FD&C yellow #6, gelatin, glycerin, mannitol*, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

*may contain this ingredient

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 INGREDIENTS IN MAXIMUM STRENGTH MUCINEX® FAST-MAX® COLD, FLU & SORE THROAT

MAXIMUM STRENGTH

Mucus Relief

COLD, FLU, & SORE THROAT

•Acetaminophen 325 mg -  Pain reliever/Fever reducer

•Dextromethorphan  HBr 10 mg - Cough Suppressant

• Guaifenesin 200 mg - Expectorant

• Phenylephrine HCI 5 mg - Nasal Decongestant

Controls Cough,

Thins & Loosens Mucus,

Relieves Nasal & Chest Congestion,

Relieves headache & fever

ADULT AGES 12+

ALCOHOL FREE

Softgels

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

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY:

GREENBRIER INTERNATIONAL, INC.

500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ASSURED Maximum Strength Mucus Relief Cold Flu Sore Throat
ASSURED Maximum Strength Mucus Relief Cold Flu Sore Throat

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33992-0838-82020-10-08C16284748780-1ab0e2407-285a-f274-e053-dbdaa90a6471Drug Facts
33992-0838-82020-09-27C16284748780-1ab0e2407-285a-f274-e053-dbdaa90a6471Drug Facts
33992-0838-82020-09-25C16284748780-1ab0e2407-285a-f274-e053-dbdaa90a6471Drug Facts
33992-0838-82020-07-22C16284748780-1ab0e2407-285a-f274-e053-dbdaa90a6471Drug Facts

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
33992-083833992-0838-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 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
7bc2ab0b-d294-46ca-a9ea-373797a5c255a9c70f34-e21d-4cb6-9bdc-ddea1a8807322021-10-07WarningsExact identifier
spl id: 7bc2ab0b-d294-46ca-a9ea-373797a5c255
spl set id: a9c70f34-e21d-4cb6-9bdc-ddea1a880732

Reported adverse events (FAERS/openFDA)#

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