FDA Label for Mucinex Fast-max Kickstart Severe Congestion And Cough And Mucinex Fast-max Nighttime Cold And Flu

Otc - Active Ingredient

Active ingredients
(in each 20 mL)
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg

Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Triprolidine HCl 2.5 mg

Otc - Purpose

Dextromethorphan HBr » Cough Suppressant
Guaifenesin » Expectorant

Acetaminophen » Pain reliever/fever reducer
Dextromethorphan » Cough suppressant
Triprolidine HCl » Antihistamine

Indications & Usage

Uses

■ 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
■ the impulse to cough to help you get
to sleep

■ temporarily relieves these common cold and flu symptoms:
■ cough ■ minor aches and pains ■ sore throat
■ headache ■ 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

Do not use
■ 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
■ persistent or chronic cough such as occurs
with smoking, asthma, chronic bronchitis, or
emphysema
■ cough that occurs with too much phlegm (mucus)

When using this product do not use more
than directed

Stop use and ask a doctor if
■ cough lasts more than 7 days, comes back, or
occurs with fever, rash, or headache that lasts.
These could be signs of a serious condition.

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 ■ 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
■ pain 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.

Dosage & Administration

Directions
■ 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

Directions
■ 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 Safety Information

Other information
■ each 20 mL contains: sodium 9 mg
■ store at 20-25°C (68-77°F)
■ do not refrigerate

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.

Inactive Ingredient

Inactive ingredients

ammonium, glycyrrhizate, anhydrous citric acid, D&C yellow
no. 10, edetate disodium, FD&C blue no. 1, flavor,
glycerin (soy), propylene glycol, purified water,
sodium benzoate, sorbitol, sucralose, trisodium
citrate dihydrate*, xanthan gum
*may contain this ingredient

Inactive ingredients ammonium
glycyrrhizate, anhydrous citric acid, edetate
disodium, FD&C blue no. 1, FD&C red no.
40, flavor, glycerin (soy), propylene glycol,
purified water, sodium benzoate, sorbitol,
sucralose, xanthan gum

Otc - Questions

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

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