Childrens Mucinex description, usages, side effects, indications, overdosage, supplying and lots more!

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Childrens Mucinex

Reckitt Benckiser LLC

Children's Mucinex® Multi-Symptom Cold & Fever


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

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

Childrens Mucinex 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

Childrens Mucinex 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,may contain this ingredient xanthan gum

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

Childrens Mucinex

acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63824-017
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 650 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 20 mg
Guaifenesin GUAIFENESIN 400 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 10 mg

Inactive Ingredients

Ingredient Name Strength
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

Color
BLUE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE
2 NDC:63824-017-64 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2011-04-04


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Be sure to consult your doctor before taking any medication!
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