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Drug Facts
Dist. by: RB Health (US), Parsippany, NJ 07054-0224
The following Structured Product Label (SPL) was submitted to the FDA by Reckitt Benckiser Llc for the product Mucinex Fast-max Severe Congestion And Cough And Mucinex Nighttime Cold And Flu (NDC 72854-166). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, uses, mucinex fast-max severe congestion & cough, mucinex nightshift cold & flu, recent major changes, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Dist. by: RB Health (US), Parsippany, NJ 07054-0224
Dextromethorphan HBr 20 mg..............Cough suppressant
Guaifenesin 400 mg.................................Expectorant
Phenylephrine HCl 10mg. . . . . . . . . . . . . . .Nasal decongestant
Acetaminophen 650mg..........Pain reliever/fever reducer
Dextromethorphan HBr 20 mg..............Cough suppressant
Phenylephrine HCl 10 mg. . . . . . . . . . . . . . . . . Nasal decongestant
Triprolidine HCl 2.5 mg. . . . . . . . . . . . . . . . . . . . . . . Antihistamine
| Active ingredients (in each 20 mL)
Mucinex Fast-Max Severe Congestion & Cough | Purposes |
|---|---|
| Dextromethorphan HBr 20 mg | Cough suppressant |
| Guaifenesin 400 mg | Expectorant |
| Phenylephrine HCl 10 mg | Nasal decongestant |
| Active ingredients (in each 20 mL)
Mucinex Nightshift Cold & Flu | Purposes |
|---|---|
| Acetaminophen 650 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 20 mg | Cough suppressant |
| Triprolidine HCl 2.5 mg | Antihistamine |
Mucinex Fast-Max Severe Congestion & Cough
■ 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 Nighttime 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
Mucinex Fast-Max Severe Congestion & Cough Clear & Cool
■ 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 Cold & Flu Clear & Cool
■ 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
Liver warning (Nighttime Cold & Flu 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 (Nighttime Cold & Flu 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 (Nighttime Cold & Flu 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.
This product contains acetaminophen. Severe liver damage may occur if you take:
Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
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.
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.
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.
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 Nighttime 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
■ each 20 mL contains: sodium
9 mg (Fast-Max Severe
Congestion & Cough only) and sodium 16 mg
(Nighttime Cold & Flu l only)
■ store at 20-25°C (68-77°F)
■ do not refrigerate
ammonium glycyrrhizate, anhydrous citric acid, edetate disodium, FD&C red no. 40, flavor, glycerin (soy), propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate*, xanthan gum *may contain this ingredient
ammonium glycyrrhizate, anhydrous citric acid, edetate disodium, FD&C blueno.1, FD&Credno.40, flavor, glycerin (soy), propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
1-866-MUCINEX (1-866-682-4639) You may also report side effects to this phone number.
DAY & NIGHT
COUGH & COLD RELIEF
MAXIMUM STRENGTH
NDC 72854-166-26
Mucinex®
FAST-MAX
®
SEVERE CONGESTION
& COUGH
Dextromethorphan HBr – Cough Suppressant
Guaifenesin – Expectorant
Phenylephrine HCl – Nasal Decongestant
Mucinex®
NIGHTTIME
COLD & FLU
Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Triprolidine HCl – Antihistamine
NIGHTTIME
RELIEF FOR A BETTER
MORNING
✓COUGH ✓FEVER ✓SORE THROAT
✓RUNNY NOSE ✓SNEEZING
FOR
AGES 12+
TWO – 6 FL OZ (180 mL) bottles
TOTAL – 12 FL OZ (360 mL)
FOR
AGES 12+
* Please review the disclaimer below.