FDA Label for Mucinex Fast-max Cold And Flu
View Indications, Usage & Precautions
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
Otc - Active Ingredient
Acetaminophen 325 mg...Pain reliever/fever reducer
Dextromethorphan HBr 10 mg...Cough suppressant
Uses
Uses
■ temporarily relieves these common cold and flu
symptoms:
■ cough due to minor throat and bronchial irritation
as may occur with the common cold or inhaled
irritants
■ the intensity of coughing
■ the impulse to cough to help you get to sleep
■ minor aches and pains
■ sore throat
■ headache
■ temporarily reduces fever
Warnings
Warnings
Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take:
■ more than 12 caplets in 24 hours, which is the
maximum daily amount for this product
■ 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.
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.
Ask a doctor before use if you have
■ liver disease
■ persistent or chronic cough such as occurs with
smoking, asthma, or emphysema
■ cough that occurs with too much phlegm (mucus)
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
Stop use and ask a doctor if
■ pain 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 rash or headache
that lasts. These could be signs of a serious condition
If pregnant or breast-feeding, ask a health
professional before use.
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
Directions
■ do not take more than directed (see Overdose
warning)
■ do not take more than 12 caplets in any 24-hour
period
■ adults and children 12 years of age and over:
take 2 caplets every 4 hours
■ children under 12 years of age: do not use
Other Safety Information
Other information
■ store at 20-25°C (68-77°F)
Inactive Ingredient
Inactive ingredients
croscarmellose sodium, FD&C red no. 40 aluminum
lake, FD&C yellow no. 6 aluminum lake,
microcrystalline cellulose, polyethylene glycol,
polyvinyl alcohol, povidone, talc, titanium dioxide
Otc - Questions
Questions? 1-866-MUCINEX (1-866-682-4639)
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Otc - Purpose
Acetaminophen » Pain Reliever/Fever Reducer
Dextromethorphan HBr » Cough Suppressant
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