MUCINEX CHILDRENS NIGHT TIME MULTI-SYMPTOM COLD- acetaminophen, diphenhydramine hydrochloride, 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 10 mL)	Purposes
Acetaminophen 325 mg	Pain reliever/fever reducer
Diphenhydramine HCl 12.5 mg	Antihistamine/cough suppressant
Phenylephrine HCl 5 mg	Nasal decongestant

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
Allergy alert

Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
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 product 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 the 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 the child is
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- do not use more than directed (see Overdose warning)
- 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 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)
- measure only with dosing cup provided
- do not use dosing cup with other products
- dose as follows or as directed by a doctor
- children 6 to under 12 years of age: 10 mL in dosing cup provided every 4 hours while symptoms last; do not give more than 5 doses in any 24-hour period
- children under 6 years of age: do not use
Other information
- each 10 mL contains: sodium 6 mg
- store between 20-25°C (68-77°F)
- do not refrigerate
Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C blue no. 1, 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: 63824-950-21

Mucinex®
Children's

NIGHT TIME
MULTI-SYMPTOM
COLD

Acetaminophen 325 mg - Pain Reliever/Fever Reducer
Diphenhydramine HCl 12.5 mg - Antihistamine/Cough Suppressant
Phenylephrine HCl 5 mg - Nasal Decongestant

✔ Relieves Stuffy Nose

✔ Controls Cough

✔ Relieves Runny Nose
& Sneezing

✔ Relieves Fever & Sore Throat

Ages
6+
yrs

Very Berry
Flavor Liquid

4 FL OZ (118 mL)

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

INGREDIENTS AND APPEARANCE

MUCINEX CHILDRENS NIGHT TIME MULTI-SYMPTOM COLD
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-950
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg in 10 mL
Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M)	Diphenhydramine Hydrochloride	12.5 mg in 10 mL
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	5 mg in 10 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
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	BLUE	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 63824-950-21	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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	05/01/2018

Labeler - RB Health (US) LLC (081049410)