Otc - Active Ingredient
Active ingredients (in each 10 mL)
Day:
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Night:
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Triprolidine HCl 1.25 mg
The following Structured Product Label (SPL) was submitted to the FDA by Reckitt Benckiser Llc for the product Mucinex Childrens (NDC 72854-062). 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 otc - active ingredient, otc - purpose, indications & usage, 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.
Active ingredients (in each 10 mL)
Day:
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Night:
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Triprolidine HCl 1.25 mg
Purpose:
Day:
Acetaminophen 325 mg...........Pain reliever/fever reducer
Dextromethorphan HBr 10 mg................Cough suppressant
Night:
Acetaminophen 325 mg...........Pain reliever/fever reducer
Dextromethorphan HBr 10 mg................Cough suppressant
Triprolidine HCl 1.25 mg............................Antihistamine
Day:
Uses
■ 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
Night:
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
Day:
Liver warning: This product contains acetaminophen. Severe liver
damage may occur if your child takes:
■ more than 5 doses (50 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.
■ 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.
Night:
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.
Day:
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
When using this product do not use more than directed (see
Overdose warning)
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.
Night:
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 even if you do not notice any signs or
symptoms.
Day:
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
Night:
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
Day:
Other information
■ each 10 mL contains: sodium 6 mg
■ store at 20-25°C (68-77°F) ■ do not refrigerate
Night:
Other information
■ each 10 mL contains: sodium 6 mg
■ store at 20-25°C (68-77°F)
■ do not refrigerate
Day:
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
Night:
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
Questions? 1-866-MUCINEX (1-866-682-4639)
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