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  5. Label Information: Maximum Strength Mucinex Fast-max Cold And Flu

FDA Label for Maximum Strength Mucinex Fast-max Cold And Flu

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. LIVER WARNING
    5. ALLERGY ALERT
    6. SORE THROAT WARNING
    7. OTC - DO NOT USE
    8. OTC - ASK DOCTOR
    9. OTC - ASK DOCTOR/PHARMACIST
    10. OTC - WHEN USING
    11. OTC - STOP USE
    12. OTC - PREGNANCY OR BREAST FEEDING
    13. OTC - KEEP OUT OF REACH OF CHILDREN
    14. OVERDOSE WARNING
    15. DIRECTIONS
    16. OTHER INFORMATION
    17. INACTIVE INGREDIENTS
    18. QUESTIONS?
    19. PRINCIPAL DISPLAY PANEL - 16 LIQUID GEL BLISTER PACK CARTON

Maximum Strength Mucinex Fast-max Cold And Flu Product Label

The following document was submitted to the FDA by the labeler of this product Rb Health (us) Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224

Made in China


Otc - Purpose



Active ingredients (in each liquid gel)Purposes
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant

Uses



  • temporarily relieves these common cold and flu symptoms:
    • nasal congestion
    • headache
    • cough
    • minor aches and pains
    • sore throat
    • sinus congestion and pressure
    • temporarily reduces fever
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Liver Warning



This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 12 liquid gels in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

Allergy Alert



Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

    • If a skin reaction occurs, stop use and seek medical help right away.


Sore Throat Warning



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.


Otc - Do Not Use



Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Otc - Ask Doctor



Ask a doctor before use if you have

  • liver disease
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin


Otc - When Using



When using this product do not use more than directed


Otc - Stop Use



Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Overdose Warning



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.


Directions



  • Do not take more than directed (see Overdose warning)
  • do not take more than 12 liquid gels in any 24-hour period
  • adults and children 12 years of age and over: take 2 liquid gels every 4 hours
  • children under 12 years of age: do not use

Other Information



  • store between 20-25°C (68-77°F)
  • avoid excessive heat

Inactive Ingredients



FD&C yellow no. 6, gelatin, glycerin, lecithin (soy), mineral oil, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide


Questions?



1-866-MUCINEX (1-866-682-4639)

You may also report side effects to this phone number.


Principal Display Panel - 16 Liquid Gel Blister Pack Carton



Fast Dissolving Liquid Gels!

NDC 63824-518-16

MAXIMUM STRENGTH
Mucinex®
FAST-MAX®

COLD & FLU

Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Guaifenesin – Expectorant • Phenylephrine HCl – Nasal Decongestant

HEADACHE
SORE THROAT
CHEST CONGESTION

BODY PAIN
FEVER
COUGH

ALL IN
ONE*

NASAL CONGESTION

SINUS CONGESTION
SINUS PRESSURE

16
LIQUID GELS
(Liquid Filled Capsules)

FOR AGES 12 +

PRINCIPAL DISPLAY PANEL - 16 Liquid Gel Blister Pack Carton - mucinex 01

PRINCIPAL DISPLAY PANEL - 16 Liquid Gel Blister Pack Carton - mucinex 01


* Please review the disclaimer below.