Your browser does not support JavaScript! MUCINEX SINUS-MAX SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [RECKITT BENCKISER LLC]
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MUCINEX SINUS-MAX SEVERE CONGESTION RELIEF (acetaminophen, guaifenesin, and phenylephrine hydrochloride) tablet, coated
[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)Purpose
Acetaminophen 325 mgPain reliever
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant

Uses

  • temporarily relieves:
    • nasal congestion
    • headache
    • minor aches and pains
    • sinus congestion and pressure
  • 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

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

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
  • 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

When using this product do not use more than directed

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 rash or persistent headache. 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 (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

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

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

PRINCIPAL DISPLAY PANEL - 20 Caplet Carton

MAXIMUM STRENGTH*

NDC 63824-201-20

NEW

Mucinex®
SINUS-MAX™

Severe Congestion Relief
Acetaminophen
- Pain Reliever • Guaifenesin - Expectorant
Phenylephrine HCl - Nasal Decongestant

Clears Sinus Congestion
Relieves Headache
Thins & Loosens Mucus

For Ages 12+

20
CAPLETS

PRINCIPAL DISPLAY PANEL - 20 Caplet Carton
MUCINEX SINUS-MAX   SEVERE CONGESTION RELIEF
acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:63824-201
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 
povidone 
talc 
titanium dioxide 
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize20mm
FlavorImprint Code VVV;CS
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-201-202 in 1 CARTON
110 in 1 BLISTER PACK
2NDC:63824-201-303 in 1 CARTON
210 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/23/2012
Labeler - Reckitt Benckiser LLC (094405024)

Revised: 8/2012
 
Reckitt Benckiser LLC

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