MUCINEX FAST-MAX COLD AND FLU ARCTIC BURST AND NIGHTSHIFT SEVERE COLD AND FLU ARCTIC BURST- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, triprolidine hydrochloride kit

Mucinex Fast-Max Cold and Flu Arctic Burst and Nightshift Severe Cold and Flu Arctic Burst by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 20 mL)	Purposes
Dextromethorphan HBr 20 mg	Cough suppressant
Guaifenesin 400 mg	Expectorant
Phenylephrine HCl 10mg	Nasal decongestant
ACETAMINOPHEN 650 mg	Pain Reliever

ACTIVE INGREDIENT

Active ingredients (in each 20 mL)	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

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
• temporarily relieves:
  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • the intensity of coughing
  • nasal congestion due to a cold
  • temporarily helps you cough less

Mucinex Nightshift

• 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 (Nightshift only)

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 (Nightshift only)

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 (Nightshift only)

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. (Nightshift only)
• 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 (Nightshift only)
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• glaucoma (Nightshift only)
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis (Nightshift 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 (Nightshift Cold & Flu Clear & Cool only)
• taking sedatives or tranquilizers (Nightshift Cold & Flu Clear & Cool only)

When using this product

• do not use more than directed
• excitability may occur, especially in children (Nightshift Cold & Flu Clear & Cool only)
• marked drowsiness may occur (Nightshift Cold & Flu Clear & Cool only)
• alcohol, sedatives, and tranquilizers may increase drowsiness (Nightshift Cold & Flu Clear & Cool only)
• avoid alcoholic drinks (Nightshift Cold & Flu Clear & Cool only)
• use caution when driving a motor vehicle or operating machinery (Nightshift Cold & Flu Clear & Cool 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 (Nightshift Cold & Flu Clear & Cool only)
• fever gets worse or lasts more than 3 days (Nightshift Cold & Flu Clear & Cool only)
• redness or swelling is present (Nightshift Cold & Flu Clear & Cool only)
• new symptoms occur (Nightshift Cold & Flu Clear & Cool only)
• symptoms do not get better within 7 days or occur with fever (Fast-Max Severe Congestion & Cough Clear & Cool only)
• 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.In case of overdose, get medical help or contact a Poison Control Center right away.

Overdose warning (Nightshift Cold & Flu Clear & Cool only)

Taking more than the recommended dose (overdose) may cause liver damage. 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 Severe Congestion & Cough Clear & Cool

• 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 Cold & Flu Clear & Cool

• 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 9 mg (Fast-Max Severe Congestion & Cough Clear & Cool only)and sodium 16 mg (Nightshift Cold & Flu Clear & Cool only)
• store at 20-25°C (68-77°F)
• do not refrigerate

Inactive ingredients

(Mucinex Fast-Max Severe Congestion & Cough Clear & Cool)

anhydrous citric acid, D&C yellow no. 10, edetate disodium, FD&C blue no. 1, flavors, glycerin, propyl gallate, propylene glycol, sodium benzoate, sodium citrate, sorbitol, sucralose, water, xanthan gum

(Mucinex Nightshift Cold & Flu Clear & Cool)

ammonium glycyrrhizate, anhydrous citric acid, D&C yellow no. 10, edetate disodium, FD&C blue no. 1, flavors, glycerin (soy), propylene glycol, sodium benzoate, sorbitol, sucralose, water, xanthan gum

Questions?

1-866-MUCINEX
(1-866-682-4639)

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - Kit Carton

MAXIMUM STRENGTH

NDC: 63824-135-26

Mucinex®
FAST-MAX ®

Acetaminophen – Pain Reliever/Fever Reducer

Dextromethorphan HBr – Cough Suppressant
Guaifenesin – Expectorant
Phenylephrine HCl – Nasal Decongestant

• Controls Cough
• Relieves Nasal & Chest Congestion
• Thins & Loosens Mucus

FOR
AGES 12+

TWO – 6 FL OZ (180 mL) bottles

Mucinex®
NIGHTSHIFT

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

NIGHTTIME
RELIEF FOR A BETTER
MORNING

✔ COUGH ✔ FEVER ✔ SORE THROAT
✔ RUNNY NOSE ✔ SNEEZING ✔ NASAL CONGESTION

TOTAL – 12 FL OZ (360 mL)

FOR
AGES 12+

INGREDIENTS AND APPEARANCE

MUCINEX FAST-MAX COLD AND FLU ARCTIC BURST AND NIGHTSHIFT SEVERE COLD AND FLU ARCTIC BURST 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, triprolidine hydrochloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72854-135

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72854-135-26	1 in 1 PACKAGE, COMBINATION	06/01/2021	05/15/2023

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

Part 1 of 2

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

Product Information
Item Code (Source)	NDC: 72854-250
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)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72854-250-66	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	07/01/2021

Part 2 of 2

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

Product Information
Item Code (Source)	NDC: 72854-133
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)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYL GALLATE (UNII: 8D4SNN7V92)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	green	Score
Shape		Size
Flavor	MENTHOL	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72854-133-66	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	07/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	06/01/2021	05/15/2025

Labeler - RB Health (US) LLC (081049410)