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

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.

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Children's Mucinex® Congestion & Cough

Drug Facts

Active ingredients (in each 5 mL)Purposes
Dextromethorphan HBr 5 mgCough suppressant
Guaifenesin 100 mgExpectorant
Phenylephrine HCl 2.5 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 your child get to sleep
    • nasal congestion due to a cold
    • stuffy nose

Warnings

Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if the child has

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with asthma

When using this product do not use more than directed

Stop use and ask a doctor if

  • your child gets nervous, dizzy or sleepless
  • 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 persistent headache. These could be signs of a serious illness.

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
  • mL = milliliter
AgeDose
children 6 years to under 12 years10 mL every 4 hours
children 4 years to under 6 years5 mL every 4 hours
children under 4 yearsdo not use

Other information

  • each 5 mL contains: sodium 3 mg
  • tamper evident: do not use if neckband on bottle cap is broken or missing
  • store between 20-25°C (68-77°F)
  • do not refrigerate
  • dosing cup provided

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate 1, xanthan gum


1
may contain this ingredient

Questions?

1-866-MUCINEX (1-866-682-4639)

You may also report side effects to this phone number.

Dist. by: Reckitt Benckiser, Parsippany, NJ 07054-0224

Made in England

PRINCIPAL DISPLAY PANEL - 201 mL Bottle Carton

NDC 63824-283-67

Children's
Mucinex®

Congestion
& Cough

Dextromethorphan HBr 5 mg      Cough Suppressant
Guaifenesin 100 mg                      Expectorant
Phenylephrine HCl 2.5 mg           Nasal Decongestant

  • Chest Congestion
  • Breaks up Mucus
  • Stuffy Nose
  • Cough

Age 4+

Berrylicious
Flavor Liquid

6.8 FL OZ
(201 mL)

Principal Display Panel - 201 mL Bottle Carton
CHILDRENS MUCINEX  CONGESTION AND COUGH
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-283
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-283-671 in 1 CARTON07/17/201209/01/2020
1201 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/17/201209/01/2020
Labeler - RB Health (US) LLC (081049410)

Revised: 5/2023
 
RB Health (US) LLC