MUCINEX FAST-MAX DAY TIME SEVERE COLD AND 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.

----------

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

Drug Facts

Active ingredients (in each caplet)Purposes
Mucinex FAST-MAX DAY TIME Severe Cold
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant

Active ingredients (in each caplet)Purposes
Mucinex FAST-MAX NIGHT TIME Cold & Flu
Acetaminophen 325 mgPain reliever/fever reducer
Diphenhydramine HCl 25 mgAntihistamine
Phenylephrine HCl 5 mgNasal decongestant

Uses

Warnings

Liver warning

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

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.
  • with any other drug containing diphenhydramine, even one used on the skin (Mucinex FAST-MAX NIGHT TIME Cold & Flu 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
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • glaucoma (Mucinex FAST-MAX NIGHT TIME Cold & Flu only)
  • a breathing problem such as emphysema or chronic bronchitis (Mucinex FAST-MAX NIGHT TIME Cold & Flu only)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (Mucinex FAST-MAX DAY TIME Severe Cold only)
  • cough that occurs with too much phlegm (mucus) (Mucinex FAST-MAX DAY TIME Severe Cold only)

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (Mucinex FAST-MAX NIGHT TIME Cold & Flu only)

When using this product

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

Stop use and ask a doctor if

  • 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 fever, rash, or headache that lasts. These could be a sign of a serious condition. (Mucinex FAST-MAX DAY TIME Severe Cold only)

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

Keep out of reach of children.

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

Other information

Inactive ingredients

(Mucinex FAST-MAX DAY TIME Severe Cold)

croscarmellose sodium, crospovidone, FD&C Red #40 aluminum lake, FD&C Yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol 3350, polyvinyl alcohol, povidone, 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 (Mucinex FAST-MAX DAY TIME Severe Cold)

PRINCIPAL DISPLAY PANEL - Kit Carton

MAXIMUM STRENGTH*

DAY TIME
NIGHT TIME

MAXIMUM STRENGTH*

NDC 63824-551-30

Mucinex®

FAST-MAX®

DAY
TIME

Severe Cold

Acetaminophen • Pain Reliever/Fever Reducer
Dextromethorphan HBr Cough Suppressant
Guaifenesin Expectorant
Phenylephrine HCl Nasal Decongestant

NEW!

Relieves Aches,
Fever & Sore Throat
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 COLD AND 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:63824-551
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-551-301 in 1 CARTON05/01/2013
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 COLD   MAXIMUM STRENGTH
acetaminophen, dextromethorphan hydrobromide, guaifenesin, 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
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)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
FD&C Red No. 40 (UNII: WZB9127XOA)  
aluminum oxide (UNII: LMI26O6933)  
FD&C Yellow No. 6 (UNII: H77VEI93A8)  
magnesium stearate (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
polyethylene glycol 3350 (UNII: G2M7P15E5P)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
talc (UNII: 7SEV7J4R1U)  
titanium dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
ColorREDScoreno score
ShapeOVALSize20mm
FlavorImprint Code VVV;MSC
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 FINALpart34105/01/2013
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 (15 MPA.S AT 5%) (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 FINALpart34105/01/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34105/01/2013
Labeler - RB Health (US) LLC (081049410)

Revised: 12/2018
Document Id: c79f9052-81ab-440a-83c0-f53a5202ded4
Set id: 8ce93565-cf00-4a50-a1f4-0c430219bf15
Version: 2
Effective Time: 20181207
 
RB Health (US) LLC