Mucinex childrens multi-symptom cough, cold and fever solution

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Drug Facts

Otc - active ingredient section

Otc - purpose section

Active ingredients (in each 10 mL) Purposes
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Guaifenesin 200 mg Expectorant
Phenylephrine HCl 5 mg Nasal 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

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)

Otc - ask doctor/pharmacist section

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

Otc - when using section

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.

Otc - keep out of reach of children section

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)
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • children 6 to under 12 years of age: 10 mL in dosing cup provided every 4 hours while symptoms last; do not give more than 5 doses in any 24-hour period
  • children under 6 years of age: do not use

Other information

  • each 10 mL contains: sodium 6 mg
  • store between 20-25C (68-77F)
  • do not refrigerate

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 dihydrate, xanthan gum

Questions?

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

You may also report side effects to this phone number.

Spl unclassified section

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

Made in England

Ingredients and appearance - Product information

Mucinex childrens multi-symptom cough, cold and fever solution- Acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 63824-948
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 325 mgin 10 mL
Dextromethorphan hydrobromide ( UNII: 9D2RTI9KYH)( Dextromethorphan - UNII: 7355X3ROTS ) 10 mgin 10 mL
Guaifenesin ( UNII: 495W7451VQ)( Guaifenesin - UNII: 495W7451VQ ) 200 mgin 10 mL
Phenylephrine hydrochloride ( UNII: 04JA59TNSJ)( Phenylephrine - UNII: 1WS297W6MV ) 5 mgin 10 mL

Inactive Ingredients

Ingredient Name Code
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

Color BLUE Flavor BERRY

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH FINAL part341 USA

Labeler - RB Health (US) LLC( 081049410)

Principal display panel - 118 ml bottle carton

Pediatrician Recommended

NDC 63824-948-27

Mucinex®
Children's

MULTI-SYMPTOM
COUGH, 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

  • Reduces Fever
  • Controls Cough
  • Relieves Stuffy Nose
  • Relieves Chest Congestion
  • Breaks up Mucus

Ages
6 +
yrs

Very Berry
Flavor Liquid

4 FL OZ (118 mL)

may contain this ingredient