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Drug Facts
Dist. by: Reckitt Benckiser, Parsippany, NJ 07054-0224
Made in England
Mucinex Fast-max Tablet, Coated
FDA Label NDC 63824-193
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 (NDC 63824-193). 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, do not use, ask a doctor before use if you have, otc - when using, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients (in each caplet) | Purposes |
|---|---|
| Dextromethorphan HBr 10 mg | Cough suppressant |
| Guaifenesin 200 mg | Expectorant |
| Phenylephrine HCl 5 mg | Nasal decongestant |
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
- nasal congestion due to a cold
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
- 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 - When Using
When using this product do not use more than directed
Stop Use And Ask A Doctor If
- nervousness, dizziness or sleeplessness occur
- symptoms do not get better within 7 days or occur with fever
- 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.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not take more than 12 caplets in any 24-hour period
- adults and children 12 years of age and older: take 2 caplets every 4 hours
- children under 12 years of age: do not use
Other Information
- tamper evident: do not use if outer package is opened or blister is torn or broken
- store between 20-25°C (68-77°F)
Inactive Ingredients
croscarmellose sodium, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, methacrylic acid-ethyl acrylate copolymer, mica, microcrystalline cellulose, polyethylene glycol 3350, polysorbate 80, polyvinyl alcohol, povidone K29/32, sodium bicarbonate, talc, titanium dioxide
Questions?
1-866-MUCINEX (1-866-682-4639)
You may also report side effects to this phone number.
Principal Display Panel - 20 Caplet Blister Pack Carton
MAXIMUM STRENGTH
NDC 63824-193-20
Mucinex®
FAST-MAX®
SEVERE CONGESTION
& COUGH
Dextromethorphan HBr – Cough Suppressant
Guaifenesin – Expectorant
Phenylephrine HCl – Nasal Decongestant
✓ Controls Cough
✓ Relieves Nasal & Chest Congestion
✓ Thins & Loosens Mucus
20 CAPLETS
FOR AGES 12+
Principal Display Panel (20 Caplet Blister Pack Carton)
* Please review the disclaimer below.
