Mucinex® FreeFrom Severe Congestion and Cough

Mucinex FreeFrom Severe Congestion and Cough by

Drug Labeling and Warnings

Mucinex FreeFrom Severe Congestion and Cough by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MUCINEX FREEFROM SEVERE CONGESTION AND COUGH- dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solution 
RB Health (US) LLC

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Mucinex® FreeFrom Severe Congestion and Cough

Drug Facts

Active ingredients (in each 20 mL)Purposes
Dextromethorphan HBr 20 mgCough suppressant
Guaifenesin 400 mgExpectorant
Phenylephrine HCl 10 mgNasal 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

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
  • high blood pressure
  • thyroid disease
  • diabetes
  • 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 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 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours
  • children under 12 years of age: do not use

Other information

  • each 20 mL contains: sodium 12 mg
  • store at 20-25°C (68-77°F)
  • do not refrigerate

Inactive ingredients

ammonium glycyrrhizate, anhydrous citric acid, edetate disodium, flavors, glycerin (soy), propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions?

1-866-MUCINEX (1-866-682-4639)You may also report side effects to this phone number.

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

PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label

Mucinex®

NDC: 63824-939-66

FREEFROM

SEVERE
CONGESTION & COUGH

DEXTROMETHORPHAN HBr – COUGH SUPPRESSANT
GUAIFENESIN – EXPECTORANT
PHENYLEPHRINE HCl – NASAL DECONGESTANT

FREEFROM
ARTIFICIAL FLAVORS, COLORS, & DYES ALCOHOL & SUGAR

HONEY
& BERRY NATURAL FLAVOR

6 FL OZ (180 mL)
FOR AGES 12+

010320
3132378

PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label
MUCINEX FREEFROM SEVERE CONGESTION AND COUGH 
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63824-939
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Color    Score    
ShapeSize
FlavorHONEYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63824-939-66180 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package06/08/202003/15/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01206/08/202003/15/2023
Labeler - RB Health (US) LLC (081049410)

Revised: 11/2023
 

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