FDA Label for Mucinex Childrens Freefrom Multi-symptom Cold, Flu And Sore Throat And Mucinex Childrens Freefrom Multi-symptom Cold And Flu Nighttime

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Mucinex Childrens Freefrom Multi-symptom Cold, Flu And Sore Throat And Mucinex Childrens Freefrom Multi-symptom Cold And Flu Nighttime 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.

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DAYTIME MULTI-SYMPTOM COLD, FLU & SORE THROAT - Ages 6+ YRS.

Drug Facts

MULTI-SYMPTOM COLD & FLU NIGHTTIME – Ages 6+ YRS.

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
Dextromethorphan HBr 10 mg	Cough suppressant
Guaifenesin 200 mg	Expectorant
Phenylephrine HCl 5 mg	Nasal decongestant

Active ingredients (in each 10 mL)	Purposes
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan HBr 10 mg	Cough suppressant
Phenylephrine HCl 5 mg	Nasal decongestant
Triprolidine HCl 1.25 mg	Antihistamine

Uses

temporarily relieves these common cold and flu symptoms:
- cough
- nasal congestion
- minor aches and pains
- sore throat
- headache
- stuffy nose
- sinus congestion and pressure
- temporarily reduces fever
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

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

This product contains acetaminophen. Severe liver damage may occur if your child takes:

more than 1625 mg 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.

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.
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.

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
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
persistent or chronic cough such as occurs with asthma
cough that occurs with too much phlegm (mucus)

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)

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin

Otc - When Using

When using this product do not use more than directed (see Overdose warning)

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
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.

Otc - Keep Out Of Reach Of Children

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

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 4 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 at 20-25°C (68-77°F)
do not refrigerate

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

Inactive Ingredients

ammonium glycyrrhizate, anhydrous citric acid, cochineal carmine, edetate disodium, flavors, glycerin (soy), maltodextrin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions?

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

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
may cause marked drowsiness
sedatives and tranquilizers may increase drowsiness

Principal Display Panel - Kit Carton

Pediatrician Recommended^†
NDC 63824-945-34

TRIPLE PACK INCLUDES:

2X DAYTIME
1X NIGHTTIME

Mucinex®
Children's

FREEFROM

MULTI-SYMPTOM
COLD, FLU
& SORE THROAT

ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUCER
DEXTROMETHORPHAN HBr – COUGH SUPPRESSANT
GUAIFENESIN – EXPECTORANT
PHENYLEPHRINE HCl – NASAL DECONGESTANT

MULTI-SYMPTOM
COLD & FLU
NIGHTTIME

ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUCER
DEXTROMETHORPHAN HBr – COUGH SUPPRESSANT
PHENYLEPHRINE HCl – NASAL DECONGESTANT
TRIPROLIDINE HCl – ANTIHISTAMINE

FREEFROM
ARTIFICIAL FLAVORS, COLORS & DYES • ALCOHOL & SUGAR

ELDERBERRY
& CHERRY NATURAL FLAVOR

AGES 6+ YRS.

THREE - 4 FL OZ (118 mL) bottles
TOTAL - 12 FL OZ (354 mL)

PRINCIPAL DISPLAY PANEL - Kit Carton - mucinex 01

* Please review the disclaimer below.

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