Childrens mucinex stuffy nose and cold solution

Spl unclassified section

Drug Facts

Otc - active ingredient section

Otc - purpose section

Active ingredients (in each 5 mL) Purposes
Guaifenesin 100 mg Expectorant
Phenylephrine HCl 2.5 mg Nasal 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

Otc - do not use section

Do not usein 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

Otc - when using section

When using this productdo not use more than directed

Otc - stop use section

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.

Otc - keep out of reach of children section

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
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

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 20-25C (68-77F)
  • 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 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: Reckitt Benckiser, Parsippany, NJ 07054-0224

Made in England

Ingredients and appearance - Product information

Childrens mucinex stuffy nose and cold solution- Guaifenesin and phenylephrine hydrochloride

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 63824-284
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Guaifenesin ( UNII: 495W7451VQ)( Guaifenesin - UNII: 495W7451VQ ) 100 mgin 5 mL
Phenylephrine hydrochloride ( UNII: 04JA59TNSJ)( Phenylephrine - UNII: 1WS297W6MV ) 2.5 mgin 5 mL

Inactive Ingredients

Ingredient Name Code
Anhydrous citric acid ( UNII: XF417D3PSL)
Edetate disodium ( UNII: 7FLD91C86K)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Glycerin ( UNII: PDC6A3C0OX)
Propylene glycol ( UNII: 6DC9Q167V3)
Propyl gallate ( UNII: 8D4SNN7V92)
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 PINK Flavor BERRY

Marketing Information

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

Labeler - Reckitt Benckiser LLC( 094405024)

Principal display panel - 118 ml bottle carton

NDC 63824-284-64

Children's
Mucinex®

Stuffy Nose &
Cold

Expectorant
Nasal Decongestant

Guaifenesin 100 mg
Phenylephrine HCl 2.5 mg

  • Stuffy Nose
  • Chest Congestion
  • Breaks up Mucus

Age 4+

Mixed Berry
Flavor Liquid

4 FL OZ
(118 mL)

may contain this ingredient