Label: MUCINEX CHILDRENS FEVER SORE THROAT AND COUGH- acetaminophen, dextromethorphan hydrobromide solution
- NDC Code(s): 72854-064-04
- Packager: RB Health (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 3, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients / Purpose (in each 10 mL)
- PURPOSE
- Uses
-
WARNINGS
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 DOCTOR
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 warfarinStop 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
-
Directions
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 SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MUCINEX CHILDRENS FEVER SORE THROAT AND COUGH
acetaminophen, dextromethorphan hydrobromide solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72854-064 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg in 10 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 10 mL Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) XANTHAN GUM (UNII: TTV12P4NEE) FD&C RED NO. 40 (UNII: WZB9127XOA) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM BENZOATE (UNII: OJ245FE5EU) Product Characteristics Color yellow Score Shape Size Flavor HONEY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72854-064-04 1 in 1 CARTON 05/01/2024 1 118 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 05/01/2024 Labeler - RB Health (US) LLC (081049410)