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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 Severe Congestion And Cough And Mucinex Nightshift Night Cold And Flu (NDC 72854-242). 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 severe congestion & cough, mucinex nightshift night cold & flu, liver warning (nightshift night cold & flu only), allergy alert (nightshift night cold & flu only), sore throat warning (nightshift night cold & flu only), 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 Severe Congestion & Cough | Purposes |
|---|---|
| Dextromethorphan HBr 10 mg | Cough suppressant |
| Guaifenesin 200 mg | Expectorant |
| Phenylephrine HCl 5 mg | Nasal decongestant |
| Active ingredients (in each caplet) Mucinex Nightshift Night Cold & Flu | Purposes |
|---|---|
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 10 mg | Cough suppressant |
| 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. 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.
croscarmellose sodium, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, methacrylic acid-ethyl acrylate copolymer, mica, microcrystalline cellulose, polyethylene glycol 3350, polysorbate 80, polyvinyl alcohol, povidone K29/32, sodium bicarbonate, talc, titanium dioxide
croscarmellose sodium, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, 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 72854-242-40
MAXIMUM STRENGTH
Mucinex®
FAST-MAX® NIGHTSHIFT
DAY
SEVERE CONGESTION
& COUGH
Dextromethorphan HBr – Cough Suppressant
Guaifenesin – Expectorant
Phenylephrine HCl – Nasal Decongestant
ACTUAL SIZE
FOR AGES 12+
24 CAPLETS
NIGHT
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
ACTUAL SIZE
FOR AGES 12+
16 CAPLETS
FAST
RELEASE
TOTAL 40 CAPLETS
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