Mucinex Fast-Max Kickstart Severe Cold & Flu and Night Time Cold & Flu

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

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

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

■ 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 SECTION

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

OTC - QUESTIONS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

PACKAGE LABEL.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)

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