MUCINEX FAST MAX LIQUID COLD AND FLU KICKSTART AND MUCINEX NIGHTSHIFT KICKSTART- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hci, triprolidine hci kit

MUCINEX FAST MAX Liquid Cold and Flu Kickstart and MUCINEX Nightshift Kickstart by

Drug Labeling and Warnings

MUCINEX FAST MAX Liquid Cold and Flu Kickstart and MUCINEX Nightshift Kickstart 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

KICKSTART SEVERE COLD & FLU:

Acetaminophen 650mg.................................Pain reliever/fever reducer
Dextromethorphan HBr 20 mg.....................................Cough suppressant
Guaifenesin 400 mg........................................................Expectorant
Phenylephrine HCl 10mg........................................Nasal decongestant

NIGHT TIME SEVERE COLD & FLU:

Acetaminophen 650mg............................ ....Pain reliever/fever reducer
Dextromethorphan HBr 20 mg....................................Cough suppressant
Phenylephrine HCl 10mg................................... . . . .Nasal decongestant
Triprolidine HCl 2.5 mg................................................Antihistamine

Uses

KICKSTART SEVERE 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

NIGHT TIME 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

KICKSTART SEVERE COLD & FLU:

Liver warning: This product contains acetaminophen. Severe liver damage may occur if
you take:
■ more than 6 doses 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.

NIGHT TIME SEVERE COLD & FLU:

Liver warning: This product contains acetaminophen. Severe liver damage may occur if
you take:
■ more than 4,000 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

■ 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
■ use caution 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 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.

Directions

KICKSTART SEVERE 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

NIGHT TIME 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

KICKSTART SEVERE COLD & FLU

■ each 20 mL contains: sodium 12 mg
■ store at 20-25°C (68-77°F)
■ do not refrigerate

NIGHT TIME SEVERE COLD & FLU

■ each 20 mL contains: sodium 16 mg
■ store at 20-25°C (68-77°F)
■ do not refrigerate

INACTIVE INGREDIENT

KICKSTART SEVERE COLD & FLU

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

NIGHT TIME 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)

KEEP OUT OF REACH OF CHILDREN

If pregnant or breast-feeding, ask a health
professional before use.
Keep out of reach of children.

Purposes

KICKSTART SEVERE COLD & FLU:

Dextromethorphan HBr 20 mg.....................................Cough suppressant
Guaifenesin 400 mg........................................................Expectorant
Phenylephrine HCl 10mg........................................Nasal decongestant

NIGHT TIME SEVERE COLD & FLU:

Dextromethorphan HBr 20 mg....................................Cough suppressant
Phenylephrine HCl 10mg................................... . . . .Nasal decongestant
Triprolidine HCl 2.5 mg................................................Antihistamine

PRINCIPAL DISPLAY PANEL

NDC: 72854-139

MUCINEX FAST-MAX Kickstart + Nighttime Cold & Flu Pack

Kickstart Severe Cold & Flu:

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

Nighttime Severe Cold & Flu:

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

FOR
AGES 12+
TWO – 6 FL OZ (180 mL) bottles

TOTAL – 12 FL OZ (360 mL)

INGREDIENTS AND APPEARANCE

MUCINEX FAST MAX LIQUID COLD AND FLU KICKSTART AND MUCINEX NIGHTSHIFT KICKSTART 
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hci, triprolidine hci kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72854-139

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72854-139-26	1 in 1 CARTON	05/01/2023

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 FAST-MAX KICKSTART SEVERE COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solution

Product Information
Item Code (Source)	NDC: 72854-138
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PROPYL GALLATE (UNII: 8D4SNN7V92)

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: 72854-138-66	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 final	part341	05/01/2023

Part 2 of 2

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

Product Information
Item Code (Source)	NDC: 72854-140
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 20 mL
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM)	TRIPROLIDINE HYDROCHLORIDE	2.5 mg  in 20 mL

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

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: 72854-140-66	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 final	part341	05/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/01/2023

Labeler - RB Health (US) LLC (081049410)