FDA Label for Childrens Mucinex Multi Symptom Cold And Childrens Mucinex Night Time Multi Symptom Cold

View Indications, Usage & Precautions

Childrens Mucinex Multi Symptom Cold And Childrens Mucinex Night Time Multi Symptom Cold Product Label

The following document was submitted to the FDA by the labeler of this product Rb Health (us). 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

Day Time Multi-Symptom Cold – Age 4+

Drug Facts

Night Time Multi-Symptom Cold – Age 6+

Drug Facts

Dist. by: Reckitt Benckiser, Parsippany, NJ 07054-0224
Made in England

Otc - Purpose

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

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

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help your child get to sleep
- nasal congestion due to a cold
- stuffy nose

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 - Ask Doctor

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

When using this product do not use more than directed

Otc - Stop Use

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

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

Keep out of reach of children.

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
dose as follows or as directed by a doctor
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

this product does not contain directions or complete warnings for adult use
do not give more than directed (see Overdose warning)
if needed, repeat dose every 4 hours while symptoms last
do not give more than 5 days unless directed by a doctor
measure only with dosing cup provided
do not use dosing cup with other products
dose as follows or as directed by a doctor
mL = milliliter
children 6 to under 12 years of age: 10 mL in dosing cup provided every 4 hours; do not give more than 5 doses in any 24-hour period
children under 6 years of age: 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 20-25°C (68-77°F)
do not refrigerate
dosing cup provided

each 10 mL contains: sodium 6 mg
store between 20-25°C (68-77°F)
dosing cup provided
do not refrigerate

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

may contain this ingredient

, xanthan gum

anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate

may contain this ingredient

, xanthan gum

Questions?

1-866-MUCINEX (1-866-682-4639)
You may also report side effects to this phone number.

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

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 drug 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 Your 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 Your 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.

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 for adults as well as for children even if you do not notice any signs or symptoms.

Principal Display Panel - Kit Carton

VALUE
PACK

NDC 63824-287-22

Children's
Mucinex®

DAY TIME

Multi-Symptom
Cold
Cough Suppressant
Expectorant
Nasal Decongestant

Dextromethorphan HBr 5 mg
Guaifenesin 100 mg
Phenylephrine HCl 2.5 mg

✓ Stuffy Nose
✓ Cough
✓ Chest Congestion
✓ Breaks up Mucus

Age 4+

Very Berry
Flavor Liquid

4 FL OZ (118 mL)

NIGHT TIME

Multi-Symptom
Cold
Pain Reliever/Fever Reducer
Antihistamine/Cough Suppressant
Nasal Decongestant

Acetaminophen 325 mg
Diphenhydramine HCl 12.5 mg
Phenylephrine HCl 5 mg

✓ Stuffy Nose
✓ Cough
✓ Runny Nose & Sneezing
✓ Fever & Sore Throat

Age 6+

Mixed Berry
Flavor Liquid