MUCINEX FAST-MAX DAY TIME SEVERE CONGESTION AND COUGH - MUCINEX FAST-MAX NIGHT TIME COLD AND FLU  MAXIMUM STRENGTH- acetaminophen, dextromethorphan hydrobromide, diphenhydramine hydrochloride, guaifenesin, and phenylephrine hydrochloride 
RB Health (US) LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Mucinex® Fast-Max® Day Time Severe Congestion and Cough - Mucinex® Fast-Max® Night Time Cold and Flu
Maximum Strength

Drug Facts

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

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

Warnings

Liver warning (NIGHT TIME only)

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)

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)

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

  • 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.

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)

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)

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)

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.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

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

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

Other information

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

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)

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?

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

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

PRINCIPAL DISPLAY PANEL - Kit Carton

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

Controls Cough
Relieves Nasal & Chest
Congestion
Thins & Loosens Mucus

NIGHT
TIME
COLD & FLU

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

Relieves Aches, Fever
& Sore Throat
Controls Cough
Relieves Nasal Congestion
Relieves Runny Nose
& Sneezing

20 CAPLETS

30 TOTAL
FOR AGES 12+

10 CAPLETS

3091260
013019

Principal Display Panel - Kit Carton
MUCINEX FAST-MAX DAY TIME SEVERE CONGESTION AND COUGH - MUCINEX FAST-MAX NIGHT TIME COLD AND FLU   MAXIMUM STRENGTH
acetaminophen, dextromethorphan hydrobromide, diphenhydramine hydrochloride, guaifenesin, and phenylephrine hydrochloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-558
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-558-301 in 1 CARTON08/25/2015
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 BLISTER PACK 20 
Part 21 BLISTER PACK 10 
Part 1 of 2
MUCINEX FAST-MAX DAY TIME SEVERE CONGESTION AND COUGH   MAXIMUM STRENGTH
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, coated
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide10 mg
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin200 mg
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride5 mg
Inactive Ingredients
Ingredient NameStrength
croscarmellose sodium (UNII: M28OL1HH48)  
FD&C blue no. 2 (UNII: L06K8R7DQK)  
aluminum oxide (UNII: LMI26O6933)  
FD&C red no. 40 (UNII: WZB9127XOA)  
mica (UNII: V8A1AW0880)  
Microcrystalline cellulose (UNII: OP1R32D61U)  
polyethylene glycol 3350 (UNII: G2M7P15E5P)  
polysorbate 80 (UNII: 6OZP39ZG8H)  
Polyvinyl alcohol, unspecified (UNII: 532B59J990)  
Povidone K30 (UNII: U725QWY32X)  
sodium bicarbonate (UNII: 8MDF5V39QO)  
talc (UNII: 7SEV7J4R1U)  
titanium dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize20mm
FlavorImprint Code VVV;SCC
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
12 in 1 CARTON
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/25/2015
Part 2 of 2
MUCINEX FAST-MAX NIGHT TIME COLD AND FLU   MAXIMUM STRENGTH
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride tablet, coated
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen325 mg
Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride12.5 mg
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride5 mg
Inactive Ingredients
Ingredient NameStrength
croscarmellose sodium (UNII: M28OL1HH48)  
crospovidone (15 mpa.s at 5%) (UNII: 68401960MK)  
FD&C blue no. 1 (UNII: H3R47K3TBD)  
FD&C blue no. 2 (UNII: L06K8R7DQK)  
ferric oxide yellow (UNII: EX438O2MRT)  
Methacrylic acid - ethyl acrylate copolymer (1:1) Type A (UNII: NX76LV5T8J)  
mica (UNII: V8A1AW0880)  
Microcrystalline cellulose (UNII: OP1R32D61U)  
Polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)  
Polyvinyl alcohol, unspecified (UNII: 532B59J990)  
Povidone K30 (UNII: U725QWY32X)  
sodium bicarbonate (UNII: 8MDF5V39QO)  
talc (UNII: 7SEV7J4R1U)  
titanium dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize20mm
FlavorImprint Code VVV;SI
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 CARTON
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/25/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/25/2015
Labeler - RB Health (US) LLC (081049410)

Revised: 12/2019
Document Id: 5afcb04b-5e21-44f2-8eb5-1c1dec9ac053
Set id: c30ccaee-d951-4b47-9a16-318131c82e0d
Version: 2
Effective Time: 20191219
 
RB Health (US) LLC