MUCINEX CHILDRENS FEVER SORE THROAT AND COUGH- acetaminophen, dextromethorphan hydrobromide solution

Mucinex Childrens Fever Sore Throat and Cough by

Drug Labeling and Warnings

Mucinex Childrens Fever Sore Throat and Cough by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients / Purpose (in each 10 mL)

Acetaminophen 325 mg..Pain reliever/fever reducer
Dextromethorphan HBr 10 mg....Cough suppressant

PURPOSE

Acetaminophen 325 mg..Pain reliever/fever reducer
Dextromethorphan HBr 10 mg....Cough suppressant

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

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 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

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

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

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

INACTIVE INGREDIENT

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

Questions? 1-866-682-4639

PRINCIPAL DISPLAY PANEL

NDC: 72854-064

Children's
Mucinex®

Honey
Flavor Liquid

4 FL OZ
(118 mL)

INGREDIENTS AND APPEARANCE

MUCINEX CHILDRENS FEVER SORE THROAT AND COUGH 
acetaminophen, dextromethorphan hydrobromide solution

Product 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)