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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 Day Cold And Flu And Mucinex Nightshift Night Severe Cold And Flu (NDC 72854-241). 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 - purpose, mucinex fast-max day cold & flu, mucinex nightshift night severe cold & flu, liver warning, allergy alert, sore throat warning, do not use, 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
| Active ingredients (in each caplet) Mucinex Fast-Max Day Cold & Flu | Purposes |
|---|---|
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 10 mg | Cough suppressant |
| Guaifenesin 200 mg | Expectorant |
| Phenylephrine HCl 5 mg | Nasal decongestant |
| Active ingredients (in each caplet) Mucinex Nightshift Night Severe Cold & Flu | Purposes |
|---|---|
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 10 mg | Cough suppressant |
| Phenylephrine HCl 5 mg | Nasal decongestant |
| Triprolidine HCl 1.25 mg | Antihistamine |
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.
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
croscarmellose sodium, crospovidone, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide
croscarmellose sodium, crospovidone, ferric oxide, hydroxypropyl cellulose, mica, microcrystalline cellulose, polyvinyl alcohol, polyvinyl alcohol polyethylene glycol copolymer, povidone, silicon dioxide, stearic acid, talc, titanium dioxide
1-866-MUCINEX (1-866-682-4639) You may also report side effects to this phone number.
FAST RELEASE. POWERFUL SYMPTOM RELIEF!
NDC 72854-241-20
MAXIMUM STRENGTH
Mucinex®
FAST-MAX® NIGHTSHIFT
DAY
COLD & FLU
Acetaminophen – Pain Reliever/
Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Guaifenesin – Expectorant
Phenylephrine HCl – Nasal Decongestant
HEADACHE
SORE THROAT
CHEST CONGESTION
BODY PAIN
FEVER
COUGH
ALL IN
ONE*
NASAL CONGESTION
SINUS CONGESTION
SINUS PRESSURE
ACTUAL SIZE
FOR AGES 12+
12 CAPLETS
FAST
RELEASE
NIGHT
SEVERE COLD & FLU
Acetaminophen – Pain Reliever/
Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Phenylephrine HCl – Nasal Decongestant
Triprolidine HCl – Antihistamine
HEADACHE
SORE THROAT
ITCHY THROAT
BODY PAIN
FEVER
COUGH
ALL IN
ONE*
NASAL CONGESTION
SNEEZING
RUNNY NOSE
ACTUAL SIZE
FOR AGES 12+
8 CAPLETS
TOTAL 20 CAPLETS
* Please review the disclaimer below.