Other
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 Maximum Strength Mucinex Fast-max Cold And Flu (NDC 63824-548). 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 cold & flu, mucinex nightshift 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 20 mL)
MUCINEX FAST-MAX COLD & FLU | Purposes |
|---|---|
| Acetaminophen 650 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 20 mg | Cough suppressant |
| Guaifenesin 400 mg | Expectorant |
| Phenylephrine HCl 10 mg | Nasal decongestant |
| Active ingredients (in each 20 mL)
MUCINEX NIGHTSHIFT SEVERE COLD & FLU | Purposes |
|---|---|
| Acetaminophen 650 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 20 mg | Cough suppressant |
| Phenylephrine HCl 10 mg | Nasal decongestant |
| Triprolidine HCl 2.5 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.
ammonium glycyrrhizate, anhydrous citric acid, edetate
disodium, FD&C blue no. 1, FD&C red no. 40, flavor,
glycerin, propyl gallate, propylene glycol, purified
water, sodium benzoate, sorbitol, sucralose,
trisodium citrate dihydrate†, xanthan gum
†may contain this ingredient
ammonium glycyrrhizate, anhydrous citric acid, ascorbic
acid, edetate disodium, FD&C blue no. 1, FD&C
red no. 40, flavors, glycerin (soy), propylene
glycol, sodium benzoate, sorbitol, sucralose,
triacetin, triethyl citrate, water, xanthan gum
1-866-MUCINEX (1-866-682-4639) You may also report side effects to this phone number.
NDC 72854-154-26
DAY & NIGHT COLD & FLU PACK
Mucinex®
FAST-MAX
®
COLD & FLU
Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Guaifenesin – Expectorant • Phenylephrine HCl – Nasal Decongestant
SORE THROAT
FEVER
HEADACHE
BODY PAIN
ALL IN
ONE*
CHEST CONGESTION
COUGH
NASAL CONGESTION
SINUS CONGESTION
SINUS PRESSURE
FOR
AGES 12+
TWO – 6 FL OZ (180 mL) bottles
MAXIMUM STRENGTH
Mucinex®
NIGHTTIME
COLD & FLU
Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Phenylephrine HCl – Nasal Decongestant • Triprolidine HCl – Antihistamine
SORE THROAT
FEVER
HEADACHE
BODY PAIN
ALL IN
ONE*
ITCHY THROAT
COUGH
NASAL CONGESTION
SNEEZING
RUNNY NOSE
TOTAL – 12 FL OZ (360 mL)
FOR
AGES 12+
* Please review the disclaimer below.