MUCINEX FAST-MAX DAY COLD AND FLU AND NIGHT COLD AND FLU MAXIMUM STRENGTH- acetaminophen, dextromethorphan hydrobromide, guaifenesin, doxylamine succinate, 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 Cold & Flu and Night Cold & Flu
Maximum Strength

Drug Facts

Active ingredients (in each liquid gel)
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 liquid gel)
Mucinex FAST-MAX NIGHT Cold & Flu
Purposes
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Doxylamine succinate 6.25 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 liquid gels 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
  • trouble urinating due to an enlarged prostate gland
  • glaucoma (NIGHT only)
  • a breathing problem such as emphysema or chronic bronchitis (NIGHT 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 (NIGHT only)

When using this product

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

Other information

Inactive ingredients (DAY only)

FD&C yellow no. 6, gelatin, glycerin, hypromellose, isopropyl alcohol, lecithin, light mineral oil, polyethylene glycol, povidone, propylene glycol, sorbitol sorbitan solution, titanium dioxide, water

Inactive ingredients (NIGHT only)

D&C yellow no. 10, FD&C blue no. 1, gelatin, glycerin, hypromellose, isopropyl alcohol, lecithin, light mineral oil, polyethylene glycol, povidone, propylene glycol, sorbitol sorbitan solution, titanium dioxide, water

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 Dissolving Liquid Gels!

NDC 72854-144-10

MAXIMUM STRENGTH
Mucinex®
FAST-MAX ®

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+


LIQUID GELS
(Liquid Filled
Capsules)

NIGHT
COLD & FLU

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

HEADACHE
SORE THROAT
ITCHY THROAT
BODY PAIN
FEVER
COUGH

ALL IN
ONE*

NASAL CONGESTION
SNEEZING
RUNNY NOSE

ACTUAL SIZE


LIQUID GELS
(Liquid Filled
Capsules)

TOTAL 10
LIQUID GELS

LabelLabel

MUCINEX FAST-MAX DAY COLD AND FLU AND NIGHT COLD AND FLU  MAXIMUM STRENGTH
acetaminophen, dextromethorphan hydrobromide, guaifenesin, doxylamine succinate, and phenylephrine hydrochloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72854-144
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72854-144-101 in 1 CARTON06/14/2023
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 13 BLISTER PACK 16 
Part 22 BLISTER PACK
Part 1 of 2
MUCINEX FAST-MAX COLD AND FLU  MAXIMUM STRENGTH
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride capsule, liquid filled
Product Information
Item Code (Source)NDC:72854-126
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
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize24mm
FlavorImprint Code AR01
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 finalpart34107/26/2021
Part 2 of 2
MUCINEX FAST MAX NIGHT COLD AND FLU 
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hci capsule, liquid filled
Product Information
Item Code (Source)NDC:72854-132
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
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorgreenScoreno score
ShapeOVALSize21mm
FlavorImprint Code AR03
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 finalpart34107/26/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/14/2023
Labeler - RB Health (US) LLC (081049410)

Revised: 6/2023
Document Id: fe44a71e-034a-174b-e053-6394a90ac0fc
Set id: fe44d1ee-1e03-b74f-e053-6294a90a8bb4
Version: 6
Effective Time: 20230616
 
RB Health (US) LLC