MUCINEX FAST-MAX  DAY TIME COLD AND FLU AND NIGHT TIME COLD AND FLU- acetaminophen, dextromethrophan hydrobromide, guaifenesin, phenylephrine hydrochloride, 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.

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Mucinex® Fast-Max®
Day Time Cold & Flu and Night Time Cold & Flu

Drug Facts

Active ingredients (in each caplet) Mucinex FAST-MAX DAY TIME COLD & FLUPurposes
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 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

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

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.
  • 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
  • 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
  • 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
  • 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 (Mucinex FAST-MAX DAY TIME COLD & FLU)

corn starch, crospovidone, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Inactive ingredients (Mucinex FAST-MAX NIGHT TIME COLD & FLU)

corn starch, croscarmellose sodium, crospovidone, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, ferric oxide yellow, magnesium stearate, methacrylic acid-ethyl acrylate copolymer (1:1) type A, mica, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium bicarbonate, stearic acid, talc, titanium dioxide

PRINCIPAL DISPLAY PANEL - Kit Carton

MAXIMUM STRENGTH

NDC 63824-516-01

Mucinex®
FAST-MAX®

DAY
TIME
COLD & FLU

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

HEADACHE
BODY PAIN
SORE THROAT
FEVER
CHEST CONGESTION
COUGH
NASAL CONGESTION
SINUS CONGESTION SINUS PRESSURE

ALL IN
ONE*

20 CAPLETS
FOR AGES 12+

NIGHT
TIME
COLD & FLU

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

HEADACHE
BODY PAIN
SORE THROAT
FEVER
ITCHY THROAT
COUGH
NASAL CONGESTION
SNEEZING RUNNY NOSE

ALL IN
ONE*

10 CAPLETS
FOR AGES 12+

TOTAL 30 CAPLETS

PRINCIPAL DISPLAY PANEL - Kit Carton
MUCINEX FAST-MAX   DAY TIME COLD AND FLU AND NIGHT TIME COLD AND FLU
acetaminophen, dextromethrophan hydrobromide, guaifenesin, phenylephrine hydrochloride, and diphenhydramine hydrochloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-516
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-516-011 in 1 PACKAGE, COMBINATION12/10/2018
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   COLD AND FLU
acetaminophen, guaifenesin, phenylephrine hydrochloride, and dextromethorphan hydrobromide tablet, film coated
Product Information
Item Code (Source)NDC:63824-514
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
starch, corn (UNII: O8232NY3SJ)  
crospovidone, unspecified (UNII: 2S7830E561)  
FD&C red no. 40 (UNII: WZB9127XOA)  
aluminum oxide (UNII: LMI26O6933)  
FD&C yellow no. 6 (UNII: H77VEI93A8)  
magnesium stearate (UNII: 70097M6I30)  
maltodextrin (UNII: 7CVR7L4A2D)  
microcrystalline cellulose (UNII: OP1R32D61U)  
polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)  
polyvinyl alcohol, unspecified (UNII: 532B59J990)  
povidone, unspecified (UNII: FZ989GH94E)  
silicon dioxide (UNII: ETJ7Z6XBU4)  
sodium starch glycolate type a potato (UNII: 5856J3G2A2)  
stearic acid (UNII: 4ELV7Z65AP)  
talc (UNII: 7SEV7J4R1U)  
titanium dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
ColorREDScoreno score
ShapeOVALSize19mm
FlavorImprint Code DCH
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-514-012 in 1 CARTON
110 in 1 BLISTER PACK; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/01/2018
Part 2 of 2
MUCINEX FAST-MAX   NIGHT TIME COLD AND FLU
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride tablet, film 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
starch, corn (UNII: O8232NY3SJ)  
croscarmellose sodium (UNII: M28OL1HH48)  
crospovidone, unspecified (UNII: 2S7830E561)  
FD&C blue no. 1 (UNII: H3R47K3TBD)  
aluminum oxide (UNII: LMI26O6933)  
FD&C blue no. 2 (UNII: L06K8R7DQK)  
ferric oxide yellow (UNII: EX438O2MRT)  
magnesium stearate (UNII: 70097M6I30)  
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, unspecified (UNII: FZ989GH94E)  
silicon dioxide (UNII: ETJ7Z6XBU4)  
sodium bicarbonate (UNII: 8MDF5V39QO)  
stearic acid (UNII: 4ELV7Z65AP)  
talc (UNII: 7SEV7J4R1U)  
titanium dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize19mm
FlavorImprint Code MVA
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 CARTON
110 in 1 BLISTER PACK; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/01/2018
Labeler - RB Health (US) LLC (081049410)

Revised: 12/2018
Document Id: 5b6d7512-02ac-4ec2-a279-c80d3abcd8b1
Set id: 8e6afd12-93fc-4eb0-b2fe-3dfc1969d315
Version: 1
Effective Time: 20181206
 
RB Health (US) LLC