Otc - Active Ingredient
| Active ingredients (in each liquid gel) | Purposes |
| Dextromethorphan HBr 10 mg | Cough suppressant |
| Guaifenesin 200 mg | Expectorant |
Mucinex Fast-max Severe Congestion And Cough Capsule, Liquid Filled
FDA Label NDC 72854-153
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Reckitt Benckiser Llc for the product Mucinex Fast-max Severe Congestion And Cough (NDC 72854-153). 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 otc - active ingredient, otc - keep out of reach of children, otc - purpose, uses, warnings, directions, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
In case of overdose, get medical help or contact a
Poison Control Center right away.
Otc - Purpose
Dextromethorphan HBr 10 mg....Cough suppressant
Guaifenesin 200mg...............................Expectorant
Uses
Uses:
■ helps loosen phlegm (mucus) and thin bronchial
secretions to rid the bronchial passageways of
bothersome mucus and make coughs more
productive
Temporarily relieves:
■ 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
Warnings
Do not use:
■ 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
■ persistent or chronic cough such as occurs with
smoking, asthma, chronic bronchitis, or emphysema
■ cough that occurs with too much phlegm (mucus)
When using this product do not use more than directed
Stop use and ask a doctor if
■ cough lasts more than 7 days, comes back, or
occurs with fever, rash, or headache that lasts.
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health
professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a
Poison Control Center right away.
Directions
■ do not take more than 12 capsules in any
24-hour period
■ adults and children 12 years of age and over:
take 2 capsules every 4 hours
■ children under 12 years of age: do not use
Other Safety Information
■ store at 20-25°C (68-77°F)
■ avoid excessive heat
Inactive Ingredient
Inactive ingredients
D&C yellow no.10, FD&C blue no. 1, gelatin,
glycerin, hypromellose, lecithin, light mineral oil,
polyethylene glycol, povidone, propylene glycol,
purified water, sorbitol sorbitan solution, titanium
dioxide
Otc - Questions
Questions? 1-866-MUCINEX (1-866-682-4639)
Package Label.Principal Display Panel
Fast Dissolving Liquid Gels!
NDC 72854-126-16
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