MUCINEX FAST-MAX DAY COLD AND FLU AND MUCINEX NIGHTSHIFT NIGHT SEVERE COLD AND FLU  MAXIMUM STRENGTH- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and triprolidine 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 Cold & Flu and Mucinex Nightshift Night Severe Cold & Flu
Maximum Strength

Drug Facts

Active ingredients (in each caplet)
Mucinex Fast-Max Day Cold & Flu
Purposes
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant
Active ingredients (in each caplet)
Mucinex Nightshift Night Severe Cold & Flu
Purposes
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Phenylephrine HCl 5 mgNasal decongestant
Triprolidine HCl 1.25 mgAntihistamine

Uses

Mucinex Fast-Max Day Cold & Flu

  • temporarily relieves these common cold and flu symptoms:
    • cough
    • nasal congestion
    • minor aches and pains
    • sore throat
    • headache
    • stuffy nose
    • sinus congestion and pressure
  • temporarily reduces fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Mucinex Nightshift Night Severe Cold & Flu

  • temporarily relieves these common cold and flu symptoms:
    • cough
    • nasal congestion
    • minor aches and pains
    • sore throat
    • headache
    • sneezing
    • sinus congestion and pressure
    • runny nose
    • itching of the nose or throat
    • itchy, watery eyes due to hay fever
  • temporarily reduces fever
  • controls cough to help you get to sleep

Warnings

Liver warning

This product contains acetaminophen.

Severe liver damage may occur if you take:

  • more than 4,000 mg 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

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

  • 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

  • liver disease
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • glaucoma (Nightshift Night Severe Cold & Flu only)
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis (Nightshift Night Severe Cold & Flu 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
  • taking sedatives or tranquilizers (Nightshift Night Severe Cold & Flu only)

When using this product

  • do not use more than directed
  • excitability may occur, especially in children (Nightshift Night Severe Cold & Flu only)
  • marked drowsiness may occur (Nightshift Night Severe Cold & Flu only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (Nightshift Night Severe Cold & Flu only)
  • avoid alcoholic drinks (Nightshift Night Severe Cold & Flu only)
  • use caution when driving a motor vehicle or operating machinery (Nightshift Night Severe 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 signs of a serious condition.

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

Mucinex Fast-Max Day Cold & Flu

  • 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

Mucinex Nightshift Night Severe Cold & Flu

  • do not take more than directed (see Overdose warning)
  • do not take more than 8 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

  • store at 20-25°C (68-77°F)

Inactive ingredients Mucinex Fast-Max Day Cold & Flu

croscarmellose sodium, crospovidone, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide

Inactive ingredients Mucinex Nightshift Night Severe Cold & Flu

croscarmellose sodium, crospovidone, ferric oxide, hydroxypropyl cellulose, mica, microcrystalline cellulose, polyvinyl alcohol, polyvinyl alcohol polyethylene glycol copolymer, povidone, silicon dioxide, stearic acid, 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

PRINCIPAL DISPLAY PANEL - Kit Carton

FAST RELEASE. POWERFUL SYMPTOM RELIEF!

NDC 72854-241-20

MAXIMUM STRENGTH
Mucinex®
FAST-MAX® NIGHTSHIFT

DAY
COLD & FLU
Acetaminophen – Pain Reliever/
Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Guaifenesin – Expectorant
Phenylephrine HCl – Nasal Decongestant

HEADACHE
SORE THROAT
CHEST CONGESTION
BODY PAIN
FEVER
COUGH

ALL IN
ONE*

NASAL CONGESTION
SINUS CONGESTION
SINUS PRESSURE

ACTUAL SIZE

FOR AGES 12+

12 CAPLETS

FAST
RELEASE

NIGHT
SEVERE COLD & FLU

Acetaminophen – Pain Reliever/
Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Phenylephrine HCl – Nasal Decongestant
Triprolidine HCl – Antihistamine

HEADACHE
SORE THROAT
ITCHY THROAT
BODY PAIN
FEVER
COUGH

ALL IN
ONE*

NASAL CONGESTION
SNEEZING
RUNNY NOSE

ACTUAL SIZE

FOR AGES 12+

8 CAPLETS

TOTAL 20 CAPLETS

Principal Display Panel - Kit Carton
MUCINEX FAST-MAX DAY COLD AND FLU AND MUCINEX NIGHTSHIFT NIGHT SEVERE COLD AND FLU   MAXIMUM STRENGTH
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and triprolidine hydrochloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72854-241
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72854-241-101 in 1 CARTON07/01/2021
11 in 1 KIT
2NDC:72854-241-202 in 1 CARTON07/01/2021
21 in 1 KIT
3NDC:72854-241-404 in 1 CARTON07/01/2021
31 in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BLISTER PACK
Part 21 BLISTER PACK
Part 1 of 2
MUCINEX FAST-MAX DAY COLD AND FLU   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 (UNII: 2S7830E561)  
FD&C red no. 40 (UNII: WZB9127XOA)  
FD&C yellow no. 6 (UNII: H77VEI93A8)  
aluminum oxide (UNII: LMI26O6933)  
magnesium stearate (UNII: 70097M6I30)  
microcrystalline cellulose (UNII: OP1R32D61U)  
polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)  
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
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/2021
Part 2 of 2
MUCINEX NIGHTSHIFT NIGHT SEVERE COLD AND FLU   MAXIMUM STRENGTH
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and triprolidine 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
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE1.25 mg
Inactive Ingredients
Ingredient NameStrength
croscarmellose sodium (UNII: M28OL1HH48)  
crospovidone (UNII: 2S7830E561)  
ferric oxide red (UNII: 1K09F3G675)  
hydroxypropyl cellulose, unspecified (UNII: 9XZ8H6N6OH)  
mica (UNII: V8A1AW0880)  
microcrystalline cellulose (UNII: OP1R32D61U)  
polyvinyl alcohol, unspecified (UNII: 532B59J990)  
polyvinyl alcohol graft polyethylene glycol copolymer (3:1; 45000 mw) (UNII: 23ZQ42JZZH)  
povidone, unspecified (UNII: FZ989GH94E)  
silicon dioxide (UNII: ETJ7Z6XBU4)  
stearic acid (UNII: 4ELV7Z65AP)  
talc (UNII: 7SEV7J4R1U)  
titanium dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
ColorYELLOWScoreno score
ShapeOVALSize19mm
FlavorImprint Code VVV;LOGOcrescentmoonplus
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/2021
Labeler - RB Health (US) LLC (081049410)

Revised: 5/2021
 
RB Health (US) LLC