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

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Childrens Mucinex

Reckitt Benckiser LLC

Children's Mucinex® Congestion & Cough


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients (in each 5 mL) Purposes
Dextromethorphan HBr 5 mg Cough suppressant
Guaifenesin 100 mg Expectorant
Phenylephrine HCl 2.5 mg Nasal decongestant

Childrens Mucinex 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 such as occurs with asthma

When using this product do not use more than directed

Stop use and ask a doctor if

  • your child gets nervous, dizzy or sleepless
  • symptoms do not get better within 7 days or occur 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 illness.

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

Directions

  • do not take more than 6 doses in any 24-hour period
  • 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
Age Dose
children 6 years to under 12 years 10 mL every 4 hours
children 4 years to under 6 years 5 mL every 4 hours
children under 4 years do not use

Childrens Mucinex Other information

  • each 5 mL contains: sodium 3 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 Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydratemay 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 - 201 mL Bottle Carton

NDC 63824-283-67

Children's
Mucinex®

Congestion
& Cough

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

  • Chest Congestion
  • Breaks up Mucus
  • Stuffy Nose
  • Cough

Age 4+

Berrylicious
Flavor Liquid

6.8 FL OZ
(201 mL)

Childrens Mucinex

Childrens Mucinex

Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63824-283
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 5 mg
Guaifenesin GUAIFENESIN 100 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 2.5 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS CITRIC ACID
EDETATE DISODIUM
FD&C RED NO. 40
GLYCERIN
propylene glycol
PROPYL GALLATE
water
SODIUM BENZOATE
sorbitol
Sucralose
TRISODIUM CITRATE DIHYDRATE
XANTHAN GUM

Product Characteristics

Color
PINK

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 201 in 1 BOTTLE
2 NDC:63824-283-67 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2012-07-17


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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