Your browser does not support JavaScript! MUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DIPHENHYDRAMINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]
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MUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (acetaminophen, guaifenesin, phenylephrine hydrochloride, and diphenhydramine hydrochloride) kit
[Reckitt Benckiser LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Drug Facts

Active ingredients (in each caplet)
Mucinex SINUS-MAX Day
Purpose
Acetaminophen 325 mgPain reliever
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant
Active ingredients (in each caplet)
Mucinex SINUS-MAX Night
Purpose
Acetaminophen 325 mgPain reliever
Diphenhydramine HCl 25 mgAntihistamine
Phenylephrine HCl 5 mgNasal decongestant

Uses

  • temporarily relieves:
    • nasal congestion
    • headache
    • minor aches and pains
    • sinus congestion and pressure
    • runny nose and sneezing (Mucinex SINUS-MAX Night only)
  • temporarily promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (Mucinex SINUS-MAX Day only)

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

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 SINUS-MAX Night 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 (Mucinex SINUS-MAX Night only)
  • a breathing problem such as emphysema or chronic bronchitis (Mucinex SINUS-MAX Night only)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema (Mucinex SINUS-MAX Day only)
  • cough that occurs with too much phlegm (mucus) (Mucinex SINUS-MAX Day only)

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (Mucinex SINUS-MAX Night only)

When using this product

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

Stop use and ask a doctor if

  • nervousness, dizziness or sleeplessness occur
  • pain or nasal congestion 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 rash or persistent headache. These could be signs of a serious condition. (Mucinex SINUS-MAX Day 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 (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • 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 and older: 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 SINUS-MAX Day)

croscarmellose sodium, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide

Inactive ingredients (Mucinex SINUS-MAX Night)

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 SINUS-MAX Day)

PRINCIPAL DISPLAY PANEL - 20 Caplet Carton

MAXIMUM STRENGTH*

NDC 63824-202-20

NEW

Mucinex®
SINUS-MAX

Day

Acetaminophen - Pain Reliever • Guaifenesin - Expectorant
Phenylephrine HCl - Nasal Decongestant

10
CAPLETS

Relieves Sinus Pressure,
Headache & Congestion
Thins & Loosens Mucus

For Ages 12+

Night

Acetaminophen - Pain Reliever • Diphenhydramine HCl - Antihistamine
Phenylephrine HCl - Nasal Decongestant

Relieves Nasal Congestion,
Sinus Pressure & Pain
Relieves Runny Nose
& Sneezing

10
CAPLETS

PRINCIPAL DISPLAY PANEL - 20 Caplet Carton
MUCINEX SINUS-MAX DAY NIGHT  MAXIMUM STRENGTH
acetaminophen, guaifenesin, phenylephrine hydrochloride, and diphenhydramine hydrochloride kit
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:63824-202
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-202-201 in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 BLISTER PACK 10 
Part 22 BLISTER PACK 10 
Part 1 of 2
MUCINEX SINUS-MAX DAY  MAXIMUM STRENGTH
acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen325 mg
Guaifenesin (Guaifenesin) Guaifenesin200 mg
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride5 mg
Inactive Ingredients
Ingredient NameStrength
croscarmellose sodium 
crospovidone 
FD&C red no. 40 
FD&C yellow no. 6 
aluminum oxide 
magnesium stearate 
cellulose, microcrystalline 
polyethylene glycols 
polyvinyl alcohol 
povidones 
talc 
titanium dioxide 
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize20mm
FlavorImprint Code VVV;CS
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
15 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/10/2012
Part 2 of 2
MUCINEX SINUS-MAX NIGHT  MAXIMUM STRENGTH
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride tablet
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen325 mg
Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine Hydrochloride25 mg
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride5 mg
Inactive Ingredients
Ingredient NameStrength
starch, corn 
croscarmellose sodium 
crospovidone 
FD&C blue no. 1 
aluminum oxide 
hypromelloses 
magnesium stearate 
cellulose, microcrystalline 
polydextrose 
polyethylene glycols 
povidones 
silicon dioxide 
stearic acid 
titanium dioxide 
triacetin 
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize20mm
FlavorImprint Code 44;544
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
15 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/10/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/10/2012
Labeler - Reckitt Benckiser LLC (094405024)

Revised: 10/2012
 
Reckitt Benckiser LLC

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