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

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Childrens Mucinex

Reckitt Benckiser LLC

Children's Mucinex® Night Time Multi-Symptom Cold


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
Diphenhydramine HCl 12.5 mg Antihistamine/cough suppressant
Phenylephrine HCl 5 mg Nasal decongestant

Childrens Mucinex Uses

  • temporarily relieves these common cold and flu symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • nasal congestion
    • runny nose
    • sneezing
    • cough
  • controls cough to help your child get to sleep
  • temporarily reduces fever

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.
  • to make a child sleepy
  • with any other drug containing diphenhydramine, even one used on the skin
  • 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
  • diabetes
  • high blood pressure
  • thyroid disease
  • glaucoma
  • 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
  • taking sedatives or tranquilizers

When using this product

  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness

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 for adults as well as for children 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)
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give more than 5 days unless directed by a doctor
  • 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 every 4 hours; do not give more than 5 doses in any 24-hour period
  • children under 6 years of age: do not use

Childrens Mucinex Other information

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

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 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 - 118 mL Bottle Carton

New!

NDC 63824-600-64

Children's
Mucinex
®

NIGHT TIME

Multi-Symptom
Cold

Pain Reliever/Fever Reducer
Antihistamine/Cough Suppressant
Nasal Decongestant

Acetaminophen 325 mg
Diphenhydramine HCl 12.5 mg
Phenylephrine HCl 5 mg

✓ Stuffy Nose
✓ Cough
✓ Runny Nose & Sneezing
✓ Fever & Sore Throat

Age 6+

Mixed Berry
Flavor Liquid

4 FL OZ
(118 mL)

Childrens Mucinex

Childrens Mucinex

Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63824-600
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 12.5 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 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 NDC:63824-600-64 118 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2013-03-25


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Be sure to consult your doctor before taking any medication!
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