MUCINEX CHILDRENS  COUGH AND CONGESTION- dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, coated 
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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Mucinex® Children's
Cough & Congestion

Drug Facts

Active ingredients (in each caplet)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 that lasts such as occurs with asthma

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 occurs 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 condition.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed (see Overdose warning)
  • dose as follows or as directed by a doctor
  • children 6 to under 12 years of age: give 2 caplets every 4 hours while symptoms last; do not give more than 6 doses in any 24-hour period
  • children under 6 years of age: do not use

Other information

  • store at 20-25°C (68-77°F)

Inactive ingredients

corn starch, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, magnesium stearate, maltodextrin, mica, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

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 - 20 Caplet Blister Pack Carton

Pediatrician Recommended†
NDC 63824-671-20
NEW

Mucinex®
Junior

COUGH & CONGESTION

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

Ages
6+
yrs

✓ Relieves Chest Congestion

✓ Breaks up Mucus

✓ Relieves Stuffy Nose

✓ Controls Cough

Junior Caplet±
Actual Size

20 CAPLETS

DO NOT CHEW

PRINCIPAL DISPLAY PANEL - 20 Caplet Blister Pack Carton
MUCINEX CHILDRENS   COUGH AND CONGESTION
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-671
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide5 mg
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin100 mg
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride2.5 mg
Inactive Ingredients
Ingredient NameStrength
starch, corn (UNII: O8232NY3SJ)  
FD&C blue no. 2 (UNII: L06K8R7DQK)  
aluminum oxide (UNII: LMI26O6933)  
FD&C red no. 40 (UNII: WZB9127XOA)  
magnesium stearate (UNII: 70097M6I30)  
maltodextrin (UNII: 7CVR7L4A2D)  
mica (UNII: V8A1AW0880)  
microcrystalline cellulose (UNII: OP1R32D61U)  
polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)  
polysorbate 80 (UNII: 6OZP39ZG8H)  
polyvinyl alcohol, unspecified (UNII: 532B59J990)  
povidone, unspecified (UNII: FZ989GH94E)  
silicon dioxide (UNII: ETJ7Z6XBU4)  
sodium starch glycolate type b potato (UNII: 27NA468985)  
stearic acid (UNII: 4ELV7Z65AP)  
talc (UNII: 7SEV7J4R1U)  
titanium dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
ColorPURPLEScoreno score
ShapeOVALSize11mm
FlavorImprint Code Mx;Jr
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-671-201 in 1 CARTON04/01/201902/25/2024
120 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34104/01/201902/25/2024
Labeler - RB Health (US) LLC (081049410)

Revised: 12/2021
Document Id: 1d3f7456-7311-4f85-b811-2d60c604063a
Set id: 94526b83-c124-476b-8af8-8656ad5ed431
Version: 2
Effective Time: 20211223
 
RB Health (US) LLC