Maximum Strength Mucinex® Fast-Max ® Cold & Flu and Mucinex® NightShift Severe Cold & Flu

Maximum Strength Mucinex Fast-Max Cold and Flu and Mucinex NightShift Severe Cold and Flu by

Drug Labeling and Warnings

Maximum Strength Mucinex Fast-Max Cold and Flu and Mucinex NightShift Severe Cold and Flu by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MAXIMUM STRENGTH MUCINEX FAST-MAX COLD AND FLU AND MUCINEX NIGHTSHIFT SEVERE COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and triprolidine hydrochloride 
RB Health (US) LLC

----------

Maximum Strength Mucinex® Fast-Max ® Cold & Flu and Mucinex® NightShift Severe Cold & Flu

Drug Facts

Active ingredients (in each 20 mL) MUCINEX FAST-MAX COLD & FLU	Purposes
Acetaminophen 650 mg	Pain reliever/fever reducer
Dextromethorphan HBr 20 mg	Cough suppressant
Guaifenesin 400 mg	Expectorant
Phenylephrine HCl 10 mg	Nasal decongestant

Active ingredients (in each 20 mL) MUCINEX NIGHTSHIFT SEVERE COLD & FLU	Purposes
Acetaminophen 650 mg	Pain reliever/fever reducer
Dextromethorphan HBr 20 mg	Cough suppressant
Phenylephrine HCl 10 mg	Nasal decongestant
Triprolidine HCl 2.5 mg	Antihistamine

Uses

MUCINEX FAST-MAX COLD & FLU

• temporarily relieves these common cold and flu symptoms:
  • cough
  • nasal congestion
  • minor aches and pains
  • sore throat
  • headache
  • stuffy nose
  • sinus congestion and pressure
• temporarily reduces fever
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

MUCINEX NIGHTSHIFT SEVERE COLD & FLU

• temporarily relieves these common cold and flu symptoms:
  • cough
  • nasal congestion
  • minor aches and pains
  • sore throat
  • headache
  • sinus congestion and pressure
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes due to hay fever
• temporarily reduces fever
• controls cough to help you get to sleep

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 4000 mg 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
• glaucoma (Nightshift Severe Cold & Flu only)
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis (Nightshift Severe Cold & Flu 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 (Nightshift Severe Cold & Flu only)

When using this product

• do not use more than directed
• excitability may occur, especially in children (Nightshift Severe Cold & Flu only)
• marked drowsiness may occur (Nightshift Severe Cold & Flu only)
• alcohol, sedatives, and tranquilizers may increase drowsiness (Nightshift Severe Cold & Flu only)
• avoid alcoholic drinks (Nightshift Severe Cold & Flu only)
• use caution when driving a motor vehicle or operating machinery (Nightshift Severe Cold & Flu 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 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

MUCINEX FAST-MAX COLD & FLU

• do not take more than directed (see Overdose warning)
• do not take more than 6 doses in any 24-hour period
• measure only with dosing cup provided
• do not use dosing cup with other products
• dose as follows or as directed by a doctor
• adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours
• children under 12 years of age: do not use

MUCINEX NIGHTSHIFT SEVERE COLD & FLU

• do not take more than directed (see Overdose warning)
• do not take more than 4 doses in any 24-hour period
• measure only with dosing cup provided
• do not use dosing cup with other products
• dose as follows or as directed by a doctor
• adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours
• children under 12 years of age: do not use

Other information

• each 20 mL contains: sodium 12 mg (Fast-Max Cold & Flu only) and sodium 16 mg (Nightshift Severe Cold & Flu only)
• store at 20-25°C (68-77°F)
• do not refrigerate

Inactive ingredients (MUCINEX FAST-MAX COLD & FLU)

anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate 1, xanthan gum

1 may contain this ingredient

Inactive ingredients (MUCINEX NIGHTSHIFT SEVERE COLD & FLU)

ammonium glycyrrhizate, anhydrous citric acid, ascorbic acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin (soy), propylene glycol, sodium benzoate, sorbitol, sucralose, triacetin, triethyl citrate, water, xanthan gum

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 - Kit Carton

NDC: 63824-139-36

MAXIMUM STRENGTH

Mucinex®
FAST-MAX ®

COLD & FLU

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

HEADACHE
BODY PAIN
SORE THROAT
FEVER
CHEST CONGESTION
COUGH
NASAL CONGESTION
SINUS CONGESTION
SINUS PRESSURE
ALL IN
ONE*

FOR AGES 12+

MAXIMUM STRENGTH

Mucinex®
NIGHTSHIFT

SEVERE COLD & FLU

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

HEADACHE
BODY PAIN
SORE THROAT
FEVER
ITCHY THROAT
COUGH
NASAL CONGESTION
SNEEZING
RUNNY NOSE
ALL IN
ONE*

FOR AGES 12+

THREE – 6 FL OZ (180 mL) bottles TOTAL – 18 FL OZ (540 mL)

MAXIMUM STRENGTH MUCINEX FAST-MAX COLD AND FLU AND MUCINEX NIGHTSHIFT SEVERE COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and triprolidine hydrochloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-139

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-139-36	1 in 1 CARTON; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)	05/07/2022	02/09/2023

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	180 mL
Part 2	2 BOTTLE	360 mL

Part 1 of 2

MUCINEX NIGHTSHIFT SEVERE COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and triprolidine hydrochloride solution

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 20 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 20 mL
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM)	TRIPROLIDINE HYDROCHLORIDE	2.5 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TRIACETIN (UNII: XHX3C3X673)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor	FRUIT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-504-66	180 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	06/01/2020

Part 2 of 2

MAXIMUM STRENGTH MUCINEX FAST-MAX COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solution

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 20 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYL GALLATE (UNII: 8D4SNN7V92)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor	FRUIT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-548-66	180 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	07/28/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	08/05/2021	02/09/2023

Labeler - RB Health (US) LLC (081049410)

Revised: 11/2023

Document Id: 0b5271fc-04c9-053c-e063-6294a90a3393

34390-5

Set id: 8c0853a5-e305-444e-ae53-4d5d83dc10b3

Version: 4

Effective Time: 20231129