Other
Drug Facts
Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224
Made in China
The following Structured Product Label (SPL) was submitted to the FDA by Reckitt Benckiser Llc for the product Maximum Strength Mucinex Fast-max Day Cold And Flu And Night Cold And Flu (NDC 63824-519). 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 China
| Active ingredients (in each liquid gel) | Purposes |
|---|---|
| Mucinex FAST-MAX DAY Cold & Flu | |
| 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 liquid gel) | Purposes |
|---|---|
| Mucinex FAST-MAX NIGHT Cold & Flu | |
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 10 mg | Cough suppressant |
| Doxylamine succinate 6.25 mg | Antihistamine |
| 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.
FD&C yellow no. 6, gelatin, glycerin, lecithin (soy), mineral oil, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide
D&C yellow no. 10, FD&C blue no. 1, gelatin, glycerin, lecithin (soy), mineral oil, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide
1-866-MUCINEX (1-866-682-4639)
You may also report side effects to this phone number.
Fast Dissolving Liquid Gels!
MAXIMUM STRENGTH
NDC 63824-519-24
Mucinex®
FAST-MAX®
DAY
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
16
LIQUID GELS
(Liquid Filled
Capsules)
NIGHT
COLD & FLU
Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Doxylamine succinate - Antihistamine
Phenylephrine HCl – Nasal Decongestant
HEADACHE
BODY PAIN
SORE THROAT
FEVER
ITCHY THROAT
COUGH
ALL IN
ONE*
NASAL CONGESTION
SNEEZING
RUNNY NOSE
8
LIQUID GELS
(Liquid Filled
Capsules)
24 TOTAL
AGES 12+
* Please review the disclaimer below.