FDA Label for Mucinex Childrens Multi-symptom Cold

View Indications, Usage & Precautions

Mucinex Childrens Multi-symptom Cold Product Label

The following document was submitted to the FDA by the labeler of this product Rb Health (us) Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other

Drug Facts

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

Made in Mexico

Otc - 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

Active ingredients (in each 5 mL)	Purposes
Dextromethorphan HBr 5 mg	Cough suppressant
Guaifenesin 100 mg	Expectorant
Phenylephrine HCl 2.5 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

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)

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

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.

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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

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

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

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 10 mL contains: sodium 6 mg
store at 20-25°C (68-77°F)
do not refrigerate

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 blue no. 1, FD&C red no. 40, flavors, glycerin (soy), propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate

may contain this ingredient

, xanthan gum

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 dihydrate

may contain this ingredient

, xanthan gum

Questions?

1-866-682-4639

You may also report side effects to this phone number.

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

You may also report side effects to this phone number.

Otc - Do Not Use

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.

Otc - When Using

When using this product do not use more than directed

Principal Display Panel - Kit Carton

Pediatrician Recommended^†
TRIPLE
PACK

NDC 63824-944-34

READ ALL INFORMATION

Mucinex®
Children's

DAY TIME
MULTI-SYMPTOM
COLD

Dextromethorphan HBr 5 mg - Cough Suppressant
Guaifenesin 100 mg - Expectorant
Phenylephrine HCl 2.5 mg - Nasal Decongestant

✔ Relieves Stuffy Nose
✔ Controls Cough
✔ Relieves Chest Congestion
✔ Breaks up Mucus

Ages
4⁺ yrs

Very Berry
Flavor Liquid

THREE – 4 FL OZ (118mL)

NIGHT TIME
MULTI-SYMPTOM
COLD

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

✔ Relieves Stuffy Nose
✔ Controls Cough
✔ Relieves Runny Nose & Sneezing
✔ Relieves Fever & Sore Throat

Ages
6⁺ yrs