MUCINEX CHILDRENS STUFFY NOSE AND CHEST CONGESTION- guaifenesin and phenylephrine hydrochloride solution

Mucinex Childrens by

Drug Labeling and Warnings

Mucinex Childrens by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

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

• nervousness, dizziness, or sleeplessness occur
• 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 condition.

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

Directions

• do not give 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

Age	Dose
children 6 to under 12 years of age	10 mL every 4 hours
children 4 to under 6 years of age	5 mL every 4 hours
children under 4 years of age	do not use

Other information

• each 5 mL contains: sodium 3 mg
• store between 20-25°C (68-77°F)
• do not refrigerate

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C red no. 40, flavors, glycerin (soy), propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate1, xanthan gum

1 may contain this ingredient

Questions?

1-866-MUCINEX (1-866-682-4639)

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Dist. by: RB Health (US)
Parsippany, NJ 07054-0224

Made in England

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

Pediatrician Recommended†

NDC: 63824-951-07

Mucinex®
Children's

STUFFY NOSE &
CHEST CONGESTION

Guaifenesin 100 mg - Expectorant
Phenylephrine HCl 2.5 mg - Nasal Decongestant

• ✔ Relieves Stuffy Nose
• ✔ Relieves Chest Congestion
• ✔ Breaks up Mucus
• ✔ Alcohol-free

Ages
4+
yrs

Very Berry
Flavor Liquid

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

MUCINEX CHILDRENS  STUFFY NOSE AND CHEST CONGESTION
guaifenesin and phenylephrine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-951
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	100 mg  in 5 mL
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	2.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYL GALLATE (UNII: 8D4SNN7V92)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
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	RED	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-951-07	1 in 1 CARTON	05/01/2018
1		118 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/01/2018

Labeler - RB Health (US) LLC (081049410)