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Mucinex Fast-Max Congestion and Headache

Medically reviewed on April 27, 2017

Dosage form: capsule, liquid filled
Ingredients: Acetaminophen 325mg, Dextromethorphan hydrobromide 10mg, Phenylephrine hydrochloride 5mg
Labeler: Reckitt Benckiser LLC
NDC Code: 63824-599

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 liquid gel)Purposes
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Phenylephrine HCl 5 mgNasal decongestant

Uses
  • temporarily relieves these common cold and flu symptoms:
    • nasal congestion
    • cough
    • headache
    • minor aches and pains
    • sinus congestion and pressure
  • temporarily reduces fever
  • temporarily promotes nasal and/or sinus drainage

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.

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, 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 liquid gels in any 24-hour period
  • adults and children 12 years of age and older: take 2 liquid gels every 4 hours
  • children under 12 years of age: do not use

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

Inactive ingredients

FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, lecithin (soy), mineral oil, polyethylene glycol, povidone, propylene glycol, sorbitol, titanium dioxide, water

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 China

PRINCIPAL DISPLAY PANEL - 16 Liquid Gel Blister Pack Carton

Fast Dissolving Liquid Gels!

MAXIMUM STRENGTH*
NDC 63824-599-16

Mucinex®
FAST-MAX®

CONGESTION &
HEADACHE

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

Relieves Headache & Fever
Controls Cough
Relieves Nasal Congestion

16
LIQUID GELS
(Liquid Filled Capsules)
DAY TIME
FOR AGES 12+

MUCINEX FAST-MAX   CONGESTION AND HEADACHE
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-599
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen325 mg
Dextromethorphan hydrobromide (Dextromethorphan) Dextromethorphan hydrobromide10 mg
Phenylephrine hydrochloride (Phenylephrine) Phenylephrine hydrochloride5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C red no. 40 
FD&C yellow no. 6 
gelatin, unspecified 
glycerin 
lecithin, soybean 
mineral oil 
polyethylene glycol, unspecified 
povidone, unspecified 
propylene glycol 
sorbitol 
titanium dioxide 
water 
Product Characteristics
ColorREDScoreno score
ShapeOVALSize20mm
FlavorImprint CodePC9
Contains    
Packaging
#Item CodePackage Description
1NDC:63824-599-162 BLISTER PACK in 1 CARTON
18 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34111/27/2015
Labeler - Reckitt Benckiser LLC (094405024)

 
Reckitt Benckiser LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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