Mucinex Fast-Max Day Time Severe Congestion and Cough Maximum Strength

Manufacturer
RB Health (US) LLC
Effective date
2019-12-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:50:05

Label at a glance#

ProductMucinex Fast-Max Day Time Severe Congestion and Cough - Mucinex Fast-Max Night Time Cold and Flu Maximum Strength
Active ingredientDextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, Acetaminophen, Diphenhydramine Hydrochloride
Label structure12 sections

Indications and uses

temporarily relieves (DAY TIME only): cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing nasal congestion due to a cold helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY TIME only) temporarily relieves these common cold and flu symptoms (...

Dosage and administration

do not take more than directed (see Overdose warning ) do not take more than 12 caplets in any 24-hour period adults and children 12 years of age and over: take 2 caplets every 4 hours children under 12 years of age: do not use

Storage and handling

store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each caplet) Mucinex FAST-MAX DAY TIME SEVERE CONGESTION & COUGHPurposes
Dextromethorphan HBr 10 mgCough suppressant
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each caplet) Mucinex FAST-MAX NIGHT TIME COLD & FLUPurposes
Acetaminophen 325 mgPain reliever/ fever reducer
Diphenhydramine HCl 12.5 mgAntihistamine/cough suppressant
Phenylephrine HCl 5 mgNasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves (DAY TIME only):
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the intensity of coughing
    • nasal congestion due to a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY TIME only)
  • temporarily relieves these common cold and flu symptoms (NIGHT TIME only):
    • cough
    • minor aches and pains
    • headache
    • nasal congestion
    • sore throat
    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes due to hay fever
  • temporarily reduces fever (NIGHT TIME only)
  • controls cough to help you get to sleep

Warnings

WARNINGS SECTION

Liver warning (NIGHT TIME only)

SPL UNCLASSIFIED SECTION

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

  • more than 12 caplets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

Allergy alert (NIGHT TIME only)

SPL UNCLASSIFIED SECTION

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 (NIGHT TIME only)

SPL UNCLASSIFIED SECTION

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.

OTC - DO NOT USE SECTION

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. (NIGHT TIME only)
  • with any other product containing diphenhydramine, even one used on the skin (NIGHT TIME only)
  • 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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin (NIGHT TIME only)
  • taking sedatives or tranquilizers (NIGHT TIME only)

OTC - WHEN USING SECTION

When using this product

  • do not use more than directed
  • excitability may occur, especially in children (NIGHT TIME only)
  • marked drowsiness may occur (NIGHT TIME only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (NIGHT TIME only)
  • avoid alcoholic drinks (NIGHT TIME only)
  • be careful when driving a motor vehicle or operating machinery (NIGHT TIME only)

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not get better within 7 days or occur with fever (DAY TIME only)
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days (NIGHT TIME only)
  • fever gets worse or lasts more than 3 days (NIGHT TIME only)
  • redness or swelling is present (NIGHT TIME only)
  • new symptoms occur (NIGHT TIME only)
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs 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.

In case of overdose, get medical help or contact a Poison Control Center right away.

SPL UNCLASSIFIED SECTION

Overdose warning (NIGHT TIME only)

Taking more than the recommended dose (overdose) may cause liver damage. 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 caplets in any 24-hour period
  • adults and children 12 years of age and over: take 2 caplets every 4 hours
  • children under 12 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)

Inactive ingredients (Mucinex FAST-MAX DAY TIME SEVERE CONGESTION & COUGH)

INACTIVE INGREDIENT SECTION

croscarmellose sodium, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, methacrylic acid-ethyl acrylate copolymer, mica, microcrystalline cellulose, polyethylene glycol 3350, polysorbate 80, polyvinyl alcohol, povidone K29/32, sodium bicarbonate, talc, titanium dioxide

Inactive ingredients (Mucinex FAST-MAX NIGHT TIME COLD & FLU)

INACTIVE INGREDIENT SECTION

croscarmellose sodium, crospovidone, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, ferric oxide yellow, methacrylic acid – ethyl acrylate copolymer (1:1) type A, mica, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium bicarbonate, talc, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

1-866-MUCINEX (1-866-682-4639) You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Dist. by: RB Health (US), Parsippany, NJ 07054-0224   Made in England

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH

DAY TIME
NIGHT TIME

MAXIMUM STRENGTH
NDC 63824-558-30

Mucinex®

FAST-MAX®

DAY
TIME
SEVERE CONGESTION
& COUGH

Dextromethorphan HBr – Cough Suppressant
Guaifenesin – Expectorant
Phenylephrine HCl – Nasal Decongestant

  1. Controls Cough
  2. Relieves Nasal & Chest
    Congestion
  3. Thins & Loosens Mucus

NIGHT
TIME
COLD & FLU

Acetaminophen - Pain Reliever/Fever Reducer
Diphenhydramine HCl - Antihistamine/
Cough Suppressant
Phenylephrine HCl - Nasal Decongestant

  1. Relieves Aches, Fever
    & Sore Throat
  2. Controls Cough
  3. Relieves Nasal Congestion
  4. Relieves Runny Nose
    & Sneezing

20 CAPLETS

30 TOTAL
FOR AGES 12+

10 CAPLETS

3091260
013019

Principal Display Panel - Kit Carton
Principal Display Panel - Kit Carton

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-558-30EA - Each63824-55871682182-ad17-43aa-9694-bf88b0de7d7812017-09-11

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63824-55863824-558-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 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
06c1eaf8-cbc9-2af7-e063-6294a90a863ec30ccaee-d951-4b47-9a16-318131c82e0d2023-10-02WarningsExact identifier
spl set id: c30ccaee-d951-4b47-9a16-318131c82e0d

Reported adverse events (FAERS/openFDA)#

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