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Mucinex Fast-Max Day Severe Cold and Night Cold and Flu

Dosage form: kit
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, GUAIFENESIN 200mg, PHENYLEPHRINE HYDROCHLORIDE 5mg; ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, DOXYLAMINE SUCCINATE 6.25mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Reckitt Benckiser LLC
NDC Code: 63824-594

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®
Day Severe Cold & Night Cold and Flu

Drug Facts

Active ingredients (in each liquid gel)
Mucinex FAST-MAX DAY Severe Cold
Purposes
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant
Active ingredients (in each liquid gel)
Mucinex FAST-MAX NIGHT Cold & Flu
Purposes
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Doxylamine succinate 6.25 mgAntihistamine
Phenylephrine HCl 5 mgNasal decongestant

Uses
  • temporarily relieves these common cold and flu symptoms:
    • cough
    • minor aches and pains
    • headache
    • nasal congestion
    • sore throat
    • runny nose and sneezing (NIGHT only)
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY only)
  • controls cough to help you get to sleep (NIGHT only)
  • temporarily reduces fever

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.

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.
  • 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 only)
  • breathing problems such as emphysema or chronic bronchitis (NIGHT 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 only)

When using this product

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

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

Inactive ingredients (NIGHT only)

D&C yellow no. 10, FD&C blue no. 1, 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 - Kit Carton

NDC 63824-594-48

48 LIQUID GELS

Fast Dissolving Liquid Gels!

MAXIMUM STRENGTH*

Mucinex®
FAST-MAX®

DAY
SEVERE COLD

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

Relieves Aches, Fever & Sore Throat
Controls Cough
Relieves Nasal & Chest Congestion
Thins & Loosens Mucus

32
LIQUID GELS
(Liquid Filled
Capsules)

48TOTAL
AGES 12+

NIGHT
COLD & FLU

Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr - Cough Suppressant
Doxylamine succinate - Antihistamine
Phenylephrine HCl - Nasal Decongestant

Relieves Aches, Fever & Sore Throat
Controls Cough
Relieves Nasal Congestion
Relieves Runny Nose & Sneezing

16
LIQUID GELS
(Liquid Filled
Capsules)

MUCINEX FAST-MAX   DAY SEVERE COLD AND NIGHT COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, and phenylephrine hydrochloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-594
Packaging
#Item CodePackage Description
1NDC:63824-594-481 KIT in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 14 BLISTER PACK 32 
Part 22 BLISTER PACK 16 
Part 1 of 2
MUCINEX FAST-MAX   DAY SEVERE COLD
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride capsule, liquid filled
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorORANGEScoreno score
ShapeOVALSize26mm
FlavorImprint CodePC26
Contains    
Packaging
#Item CodePackage Description
14 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 finalpart34107/15/2015
Part 2 of 2
MUCINEX FAST-MAX   NIGHT COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride capsule, liquid filled
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE6.25 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
GELATIN, UNSPECIFIED 
GLYCERIN 
LECITHIN, SOYBEAN 
MINERAL OIL 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POVIDONE, UNSPECIFIED 
PROPYLENE GLYCOL 
SORBITOL 
TITANIUM DIOXIDE 
WATER 
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize20mm
FlavorImprint CodePC22
Contains    
Packaging
#Item CodePackage Description
12 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 finalpart34107/15/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/15/2015
Labeler - Reckitt Benckiser LLC (094405024)

Revised: 05/2017
 
Reckitt Benckiser LLC

← See all Mucinex Fast-Max Day Severe Cold and Night Cold and Flu brands

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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