Active Ingredients / Purpose (In Each 10 Ml)
Acetaminophen 325 mg..Pain reliever/fever reducer
Dextromethorphan HBr 10 mg....Cough suppressant
The following Structured Product Label (SPL) was submitted to the FDA by Reckitt Benckiser Llc for the product Mucinex Childrens Fever Sore Throat And Cough (NDC 72854-064). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients / purpose (in each 10 ml), otc - purpose, uses, warnings, otc - ask doctor, otc - keep out of reach of children, directions, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 325 mg..Pain reliever/fever reducer
Dextromethorphan HBr 10 mg....Cough suppressant
Acetaminophen 325 mg..Pain reliever/fever reducer
Dextromethorphan HBr 10 mg....Cough suppressant
■ 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
■ minor aches and pains
■ sore throat
■ headache
■ 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.
■ 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
■ chronic cough that lasts 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
Stop use and ask a doctor if
■ pain 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 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 at 20-25°C (68-77°F)
■ do not refrigerate
Inactive ingredients: anhydrous citric acid,
D&C yellow no. 10, edetate disodium, FD&C red
no. 40, flavors, glycerin, propylene glycol,
purified water, sodium benzoate, sorbitol,
sucralose, xanthan gum
Questions? 1-866-682-4639
NDC 72854-064
Children's
Mucinex®
Honey
Flavor Liquid
4 FL OZ
(118 mL)
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