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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 Rb Health (us) Llc for the product Maximum Strength Mucinex Fast-max Day Time Cold And Flu And Night Time Cold And Flu (NDC 63824-511). 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 time cold & flu, mucinex fast-max night time 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) | Purposes |
|---|---|
| Mucinex FAST-MAX DAY TIME COLD & FLU | |
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 10mg | Cough suppressant |
| Guaifenesin 200 mg | Expectorant |
| Phenylephrine HCl 5 mg | Nasal decongestant |
| Active ingredients (in each caplet) | Purposes |
|---|---|
| Mucinex FAST-MAX NIGHT TIME COLD & FLU | |
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Diphenhydramine HCl 12.5 mg | Antihistamine/cough suppressant |
| Phenylephrine HCl 5 mg | Nasal decongestant |
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.
(Mucinex FAST-MAX DAY TIME COLD & FLU)
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
(Mucinex FAST-MAX NIGHT TIME COLD & FLU)
croscarmellose sodium, crospovidone, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, ferric oxide yellow, methacrylic acid – ethyl acrylate copolymer (1:1) type A, mica, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium bicarbonate, talc, titanium dioxide
NDC 63824-511-40
MAXIMUM STRENGTH
Mucinex®
FAST-MAX®
DAY
TIME
COLD & FLU
Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Guaifenesin – Expectorant
Phenylephrine HCl – Nasal Decongestant
HEADACHE
BODY PAIN
SORE THROAT
FEVER
CHEST CONGESTION
COUGH
ALL IN
ONE*
NASAL CONGESTION
SINUS CONGESTION
SINUS PRESSURE
Actual Size
FOR AGES 12+
24 CAPLETS
NIGHT
TIME
COLD & FLU
Acetaminophen – Pain Reliever/Fever Reducer
Diphenhydramine HCl – Antihistamine/
Cough Suppressant
Phenylephrine HCl – Nasal Decongestant
HEADACHE
BODY PAIN
SORE THROAT
FEVER
ITCHY THROAT
COUGH
ALL IN
ONE*
NASAL CONGESTION
SNEEZING
RUNNY NOSE
Actual Size
FOR AGES 12+
16 CAPLETS
TOTAL 40 CAPLETS
* Please review the disclaimer below.