MUCINEX FAST-MAX DAY TIME SEVERE CONGESTION AND COUGH AND MUCINEX FAST-MAX NIGHT TIME COLD AND FLU  MAXIMUM STRENGTH- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, acetaminophen, and diphenhydramine 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.

----------

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

Drug Facts

Active ingredients (in each caplet)
Mucinex FAST-MAX DAY TIME Severe Congestion & Cough
Purposes
Dextromethorphan HBr 10 mgCough suppressant
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant

Active ingredients (in each caplet)
Mucinex FAST-MAX NIGHT TIME Cold & Flu
Purposes
Acetaminophen 325 mgPain reliever/fever reducer
Diphenhydramine HCl 25 mgAntihistamine
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 that contain acetaminophen
  • 3 or more alcoholic drinks daily while using this product

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 drug 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.
  • for children under 12 years of age

Ask a doctor before use if you have

  • liver disease (NIGHT TIME only)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • 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 (DAY TIME only)
  • cough that occurs with too much phlegm (mucus) (DAY TIME only)

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. In addition, for NIGHT TIME only:

  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not get better within 7 days or occur with a 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 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

Taking more than the recommended dose (overdose) may cause liver damage. (NIGHT TIME only)

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 #2 aluminum lake, FD&C Red #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)

corn starch, croscarmellose sodium, crospovidone, FD&C Blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silicon dioxide, stearic acid, titanium dioxide, triacetin

Questions?

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

Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224

Made in England

PRINCIPAL DISPLAY PANEL - Kit Carton

MAXIMUM STRENGTH*

NDC 63824-555-30

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

AGES 12+

20 CAPLETS

NIGHT
TIME
Cold & Flu

Acetaminophen • Pain Reliever/Fever Reducer
Diphenhydramine HCl • Antihistamine
Phenylephrine HCl • Nasal Decongestant

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

10 CAPLETS

Principal Display Panel - Kit Carton
MUCINEX FAST-MAX DAY TIME SEVERE CONGESTION AND COUGH AND MUCINEX FAST-MAX NIGHT TIME COLD AND FLU   MAXIMUM STRENGTH
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, acetaminophen, and diphenhydramine hydrochloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-555
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-555-301 in 1 CARTON04/25/2014
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
ColorREDScoreno score
ShapeOVALSize20mm
FlavorImprint Code VVV;SCC
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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 finalpart34103/15/2013
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 Hydrochloride25 mg
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride5 mg
Inactive Ingredients
Ingredient NameStrength
starch, corn (UNII: O8232NY3SJ)  
croscarmellose sodium (UNII: M28OL1HH48)  
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
FD&C Blue No. 1 (UNII: H3R47K3TBD)  
aluminum oxide (UNII: LMI26O6933)  
hypromellose, unspecified (UNII: 3NXW29V3WO)  
magnesium stearate (UNII: 70097M6I30)  
microcrystalline cellulose (UNII: OP1R32D61U)  
polydextrose (UNII: VH2XOU12IE)  
polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)  
povidone, unspecified (UNII: FZ989GH94E)  
silicon dioxide (UNII: ETJ7Z6XBU4)  
stearic acid (UNII: 4ELV7Z65AP)  
titanium dioxide (UNII: 15FIX9V2JP)  
triacetin (UNII: XHX3C3X673)  
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize20mm
FlavorImprint Code 44;544
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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 finalpart34104/30/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/25/2014
Labeler - RB Health (US) LLC (081049410)

Revised: 1/2022
Document Id: 85084eef-ac73-450f-a42f-78364bc7456c
Set id: 815f0ec8-d89d-4e74-8328-5e3b30fbe3ec
Version: 3
Effective Time: 20220113
 
RB Health (US) LLC