Other
Drug Facts
Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224
Made in England
The following Structured Product Label (SPL) was submitted to the FDA by Reckitt Benckiser Llc for the product Maximum Strength Mucinex Fast-max Cold And Flu (NDC 63824-575). 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, uses, liver warning, allergy alert, sore throat warning, do not use, ask a doctor before use if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224
Made in England
| Active ingredients(in each caplet) | Purposes |
|---|---|
| Acetaminophen 325mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 10 mg | Cough suppressant |
| Guaifenesin 200mg | Expectorant |
| Phenylephrine HCl 5 mg | Nasal decongestant |
temporarily relieves these common cold and flu symptoms:
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.
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
When using this product do not use more than directed
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
1-866-MUCINEX(1-866-682-4639) You may also report side effects to this phone number.
NDC 63824-575-44
MAXIMUM STRENGTH
Mucinex®
FAST-MAX®
COLD & FLU
Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Guaifenesin – Expectorant • Phenylephrine HCI – Nasal Decongestant
HEADACHE
SORE THROAT
CHEST CONGESTION
BODY PAIN
FEVER
COUGH
ALL IN
ONE*
NASAL CONGESTION
SINUS CONGESTION
SINUS PRESSURE
8 CAPLETS
(4 Pouches: 2 Caplets each)
FOR AGES 12+
* Please review the disclaimer below.