MUCINEX CHILDRENS  MULTI-SYMPTOM COLD AND SORE THROAT- acetaminophen, 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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Mucinex Children's
Multi-Symptom Cold & Sore Throat

Drug Facts

Active ingredients (in each 10 mL)Purposes
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant

Uses

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if your child takes

  • more than 5 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen

Allergy alert

Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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

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

Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin

When using this product do not use more than directed (see Overdose warning)

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

Keep out of reach of children.

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

Other information

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin (soy), propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate1, 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: RB Health (US)
Parsippany, NJ 07054-0224

Made in England

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

Pediatrician Recommended

NDC 63824-952-17

Mucinex®
Children's

MULTI-SYMPTOM
COLD &
SORE THROAT

Acetaminophen 325 mg - Pain Reliever/Fever Reducer
Dextromethorphan HBr 10 mg - Cough Suppressant
Guaifenesin 200 mg - Expectorant
Phenylephrine HCl 5 mg - Nasal Decongestant

Relieves Sore Throat
Relieves Stuffy Nose
Relieves Chest
Congestion and Cough
Breaks up Mucus

Ages
6+
yrs

Very Berry
Flavor Liquid

4 FL OZ (118 mL)

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
MUCINEX CHILDRENS   MULTI-SYMPTOM COLD AND SORE THROAT
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-952
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 10 mL
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide10 mg  in 10 mL
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin200 mg  in 10 mL
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride5 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-952-171 in 1 CARTON05/01/2018
1118 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34105/01/2018
Labeler - RB Health (US) LLC (081049410)

Revised: 1/2022
Document Id: d2cf33a1-0337-4f5f-b0d9-5b516360e5b6
Set id: 8f3eb5c5-832e-4806-b3da-ef112cf55dcf
Version: 3
Effective Time: 20220111
 
RB Health (US) LLC