MAXIMUM STRENGTH MUCINEX FAST-MAX COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, film coated 
RB Health (US) LLC

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Mucinex® Fast-Max ®

Cold & Flu

Drug Facts

Active ingredients (in each caplet)Purposes
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant

Uses

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.

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
  • 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 fever, 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

Other information

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: RB Health (US)
Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 20 Caplet Blister Pack Carton

NDC 63824-575-21

MAXIMUM STRENGTH

Mucinex®

FAST-MAX ®

COLD & FLU

Acetaminophen – Pain Reliever/Fever Reducer

Dextromethorphan HBr – Cough Suppressant

Guaifenesin – Expectorant

Phenylephrine HCl – Nasal Decongestant

SORE THROAT

FEVER

CHEST CONGESTION

COUGH

NASAL CONGESTION

SINUS CONGESTION

SINUS PRESSURE

HEADACHE

BODY PAIN

ALL IN

ONE*

Actual Size

20 CAPLETS

FOR AGES 12+

Label

MAXIMUM STRENGTH MUCINEX FAST-MAX COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-575
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CROSPOVIDONE (UNII: 2S7830E561)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorredScoreno score
ShapeOVALSize20mm
FlavorImprint Code MSC;VVV
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-575-202 in 1 CARTON07/28/201805/03/2024
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:63824-575-444 in 1 CARTON07/28/2018
2NDC:63824-575-722 in 1 POUCH; Type 0: Not a Combination Product
3NDC:63824-575-212 in 1 CARTON09/01/2020
310 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:63824-575-101 in 1 CARTON07/12/2021
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:63824-575-041 in 1 CARTON07/28/2018
52 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01207/28/2018
Labeler - RB Health (US) LLC (081049410)

Revised: 11/2023
Document Id: 0b52fe45-ebac-2345-e063-6394a90ae873
Set id: 8a790eeb-7d7d-4a94-9103-6ed09c04d596
Version: 8
Effective Time: 20231129
 
RB Health (US) LLC