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Mucinex Fast-Max Congestion and Headache

Medically reviewed on August 3, 2016

Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 325mg, GUAIFENESIN 200mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Reckitt Benckiser LLC
NDC Code: 63824-236

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.

Mucinex® Fast-Max®
Congestion & Headache

Drug Facts

Active Ingredients (in each caplet)Purposes
Acetaminophen 325 mgPain reliever/fever reducer
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant

Uses
  • temporarily relieves these common cold and flu symptoms:
    • nasal congestion
    • fever
    • 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

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.

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 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
  • 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 older: take 2 caplets every 4 hours
  • children under 12 years of age: do not use

Other information
  • store between 20-25°C (68-77°F)

Inactive ingredients

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

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 Blister Pack Carton

MAXIMUM STRENGTH*
NDC 63824-236-20

Mucinex®
FAST-MAX®

CONGESTION &
HEADACHE

Acetaminophen – Pain Reliever/Fever Reducer
Guaifenesin – Expectorant
Phenylephrine HCl – Nasal Decongestant

Relieves Headache & Fever
Relieves Nasal & Chest Congestion
Thins & Loosens Mucus

20 CAPLETS
FOR AGES 12+

MUCINEX FAST-MAX   CONGESTION AND HEADACHE
acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-236
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 (15 mpa.s at 5%) 
FD&C red no. 40 
aluminum oxide 
FD&C yellow no. 6 
magnesium stearate 
cellulose, microcrystalline 
polyethylene glycol, unspecified 
polyvinyl alcohol, unspecified 
povidones 
talc 
titanium dioxide 
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize20mm
FlavorImprint CodeVVV;CS
Contains    
Packaging
#Item CodePackage Description
1NDC:63824-236-202 BLISTER PACK in 1 CARTON
110 TABLET, COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34110/01/2016
Labeler - Reckitt Benckiser LLC (094405024)

 
Reckitt Benckiser LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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