Maximum strength mucinex fast max severe congestion and cough

• NDC Code(s): 63824-193-20, 63824-193-21, 63824-193-30
• Packager: RB Health (US) LLC

• Category: HUMAN OTC DRUG LABEL
• DEA Schedule: None
• Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 12, 2022

If you are a consumer or patient please visit this version.

• SPL UNCLASSIFIED SECTION
• ACTIVE INGREDIENT
• 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

• 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

  • 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)

  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.

  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 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 information
  • store at 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.

• SPL UNCLASSIFIED SECTION

  Dist. by: RB Health (US)
  Parsippany, NJ 07054-0224

• Principal Display Panel - 20 Caplet Blister Pack Carton

  MAXIMUM STRENGTH
  NDC 63824-193-21

  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

  Actual Size

  20 CAPLETS
  FOR AGES 12+