MUCINEX FAST-MAX  NIGHT TIME COLD AND FLU- acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride tablet, film coated 
RB Health (US) LLC

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.

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Mucinex® Fast-Max ®

Night Time Cold & Flu

Drug Facts

Active ingredients (in each caplet)Purposes
Acetaminophen 325 mgPain reliever/fever reducer
Diphenhydramine HCl 12.5 mgAntihistamine/cough suppressant
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.
  • with any other product containing diphenhydramine, even one used on the skin
  • 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
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • 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
  • taking sedatives or tranquilizers

When using this product

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

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse or lasts more than 7days
  • 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 blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, ferric oxide yellow, methacrylic acid – ethyl acrylate copolymer (1:1) type A, mica, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium bicarbonate, 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
Made in England

PRINCIPAL DISPLAY PANEL - 8 Caplet Pouch Carton

NDC 63824-793-08

MAXIMUM STRENGTH

Mucinex®

FAST-MAX ®

NIGHT TIME COLD & FLU

Acetaminophen – Pain Reliever/Fever Reducer

Diphenhydramine HCl – Antihistamine/Cough Suppressant

Phenylephrine HCl – Nasal Decongestant

HEADACHE

SORE THROAT

ITCHY THROAT

BODY PAIN

FEVER

COUGH

ALL IN

ONE*

NASAL CONGESTION

SNEEZING

RUNNY NOSE

8 CAPLETS

(4 Pouches: 2 Caplets each)

FOR AGES 12+

Label

MUCINEX FAST-MAX   NIGHT TIME COLD AND FLU
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-793
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CROSPOVIDONE (UNII: 2S7830E561)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
MICA (UNII: V8A1AW0880)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorblueScoreno score
ShapeOVALSize20mm
FlavorImprint Code VVV;CF
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-793-084 in 1 CARTON09/10/2018
1NDC:63824-793-022 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/10/2018
Labeler - RB Health (US) LLC (081049410)

Revised: 5/2022
Document Id: deabbe4b-ef9e-4368-e053-2a95a90a2d24
Set id: ce0c2550-39ab-4393-afb5-7d8889733768
Version: 6
Effective Time: 20220510
 
RB Health (US) LLC