Pill Identifier App

Childrens Mucinex Multi-Symptom Cold and Fever

Dosage form: solution
Ingredients: acetaminophen 650mg in 20mL, dextromethorphan hydrobromide 20mg in 20mL, guaifenesin 400mg in 20mL, phenylephrine hydrochloride 10mg in 20mL
Labeler: Reckitt Benckiser LLC
NDC Code: 63824-017

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.

Children's
Mucinex®
Multi-Symptom
Cold & Fever

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
  • temporarily relieves these common cold and flu symptoms:
    • nasal congestion
    • stuffy nose
    • cough due to minor throat and bronchial irritation
    • the intensity of coughing
    • the impulse to cough to help your child get to sleep
    • minor aches and pains
    • sore throat
    • headache
  • temporarily reduces fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

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

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 your child has
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • a breathing problem such as chronic bronchitis
  • 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 your 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 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
  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed
    (see Overdose warning)
  • do not give more than 5 doses in any 24-hour period
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give more than 5 days unless directed by a doctor
  • shake well before using
  • 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
  • children 6 to under 12 years of age: 10 mL in dosing cup provided
  • children under 6 years of age: do not use

Other information
  • each 10 mL contains: sodium 6 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 Blue #1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum


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 - 118 mL Bottle Carton

NDC 63824-017-64

Children's
Mucinex®

Multi-Symptom
Cold & Fever

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

Fever
Cough
Stuffy Nose
Chest Congestion
Breaks up Mucus

Age 6+

Berry Blast
Flavor Liquid

4 FL OZ
(118 mL)

CHILDRENS MUCINEX   MULTI-SYMPTOM COLD AND FEVER
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-017
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
acetaminophen (acetaminophen) acetaminophen650 mg  in 20 mL
dextromethorphan hydrobromide (dextromethorphan) dextromethorphan hydrobromide20 mg  in 20 mL
guaifenesin (guaifenesin) guaifenesin400 mg  in 20 mL
phenylephrine hydrochloride (phenylephrine) phenylephrine hydrochloride10 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid 
edetate disodium 
FD&C Blue NO. 1 
FD&C Red NO. 40 
glycerin 
propylene glycol 
propyl gallate 
water 
sodium benzoate 
sorbitol 
sucralose 
trisodium citrate dihydrate 
xanthan gum 
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63824-017-641 BOTTLE in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34104/04/2011
Labeler - Reckitt Benckiser LLC (094405024)

Revised: 09/2013
 
Reckitt Benckiser LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web3)