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Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Reckitt Benckiser Llc for the product Mucinex Childrens (NDC 72854-063). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor/pharmacist, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Active ingredients (in each 10 mL)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Triprolidine HCl 1.25 mg
Acetaminophen 325 mg - Pain reliever/fever reducer
Dextromethorphan HBr 10 mg - Cough suppressant
Triprolidine HCl 1.25 mg.........................Antihistamine
Uses
■ temporarily relieves these common cold and flu
symptoms:
■ cough ■ minor aches and pains ■ sore throat
■ headache ■ runny nose ■ sneezing
■ itching of the nose or throat
■ itchy, watery eyes due to hay fever
■ temporarily reduces fever
■ controls cough to help your child get to sleep
Warnings
Liver warning: This product contains acetaminophen.
Severe liver damage may occur if your child takes:
■ more than 4 doses (40 mL) in 24 hours, which is the
maximum daily amount for this product
■ 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
■ 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 ■ 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
■ 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 for
children even if you do not notice any signs or
symptoms.
Keep out of reach of children.
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 4 doses in any 24-hour period
■ children under 6 years of age: do not use
■ 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, edetate
disodium, FD&C red no. 40, FD&C yellow no. 10, flavors,
glycerin (soy), propylene glycol, purified water, sodium
benzoate, sorbitol, sucralose, xanthan gum
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