Mucinex Fast-max Kickstart Severe Cold & Flu And Night Time Cold & Flu

Mucinex Fast-max Kickstart Severe Cold & Flu And Night Time Cold & Flu
SPL v2
SPL
SPL Set ID fdb70793-5dd1-0455-e053-6394a90ac621
Route
ORAL
Published
Effective Date 2023-06-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (10 mg) Dextromethorphan (20 mg) Guaifenesin (400 mg) Acetaminophen (650 mg) Triprolidine (2.5 mg)
Inactive Ingredients
D&c Yellow No. 10 Fd&c Blue No. 1 Sodium Citrate, Unspecified Form Sorbitol Sucralose Xanthan Gum Water Glycerin Propylene Glycol Sodium Benzoate Anhydrous Citric Acid Edetate Disodium Propyl Gallate Fd&c Red No. 40 Triethyl Citrate Ammonium Glycyrrhizate Ascorbic Acid Triacetin

Identifiers & Packaging

Pill Appearance
Color: green Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-05-01

Description

Drug Facts

Purpose

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


Medication Information

Purpose

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

Description

Drug Facts

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

Section 42229-5

Drug Facts

Section 50565-1

If pregnant or breast-feeding, ask a health

professional before use.

Keep out of reach of children.

Section 51727-6

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

Section 51945-4

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)

Section 53413-1

1-866-MUCINEX

(1-866-682-4639)

Section 55106-9

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

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

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


Structured Label Content

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

If pregnant or breast-feeding, ask a health

professional before use.

Keep out of reach of children.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

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)

Section 53413-1 (53413-1)

1-866-MUCINEX

(1-866-682-4639)

Section 55106-9 (55106-9)

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

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

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


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