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Childrens Mucinex Stuffy Nose and Cold

Dosage form: solution
Ingredients: Guaifenesin 100mg in 5mL, Phenylephrine Hydrochloride 2.5mg in 5mL
Labeler: Reckitt Benckiser LLC
NDC Code: 63824-277

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® Stuffy Nose & Cold

Drug Facts

Active ingredients
(in each 5 mL)
Purpose
Guaifenesin 100 mgExpectorant
Phenylephrine HCl 2.5 mgNasal decongestant

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves:
    • 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
  • mL = milliliter
AgeDose
children 6 years to under 12 years10 mL every 4 hours
children 4 years to under 6 years5 mL every 4 hours
children under 4 yearsdo not use

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, dextrose, D&C red #33, FD&C blue #1, FD&C red #40, flavors, glycerin, methylparaben, potassium sorbate, propyl gallate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sorbitol, sucralose, 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

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

NDC 63824-277-64

Children's
Mucinex
®

Stuffy Nose &
Cold
Expectorant
Nasal Decongestant

Guaifenesin 100 mg
Phenylephrine HCl 2.5 mg

Stuffy Nose
Chest Congestion
Breaks up Mucus

Mixed Berry
Flavor Liquid

4 FL OZ
(118 mL)

CHILDRENS MUCINEX   STUFFY NOSE AND COLD
guaifenesin and phenylephrine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-277
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (Guaifenesin) Guaifenesin100 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid 
dextrose 
D&C red No. 33 
FD&C blue No. 1 
FD&C red No. 40 
glycerin 
methylparaben 
potassium sorbate 
propyl gallate 
propylene glycol 
propylparaben 
water 
saccharin sodium dihydrate 
sodium hydroxide 
sorbitol 
sucralose 
xanthan gum 
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63824-277-641 BOTTLE in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/18/2012
Labeler - Reckitt Benckiser LLC (094405024)

Revised: 06/2012
 
Reckitt Benckiser LLC

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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.

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