Mucinex Children's Fever, Sore Throat & Cough

Mucinex Children's Fever, Sore Throat & Cough
SPL v1
SPL
SPL Set ID 1538a75d-582a-9501-e063-6394a90a6c55
Route
ORAL
Published
Effective Date 2024-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg)
Inactive Ingredients
Propylene Glycol Anhydrous Citric Acid Water Glycerin D&c Yellow No. 10 Xanthan Gum Fd&c Red No. 40 Sorbitol Sucralose Edetate Disodium Sodium Benzoate

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-01

Description

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


Medication Information

Warnings and Precautions

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.

Purpose

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

Description

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

Section 50565-1

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

Section 50569-3

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.

Section 51727-6

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

Section 51945-4

NDC 72854-064

Children's

Mucinex®

Honey

Flavor Liquid

4 FL OZ

(118 mL)

Section 53413-1

Questions? 1-866-682-4639

Section 55105-1

Acetaminophen 325 mg..Pain reliever/fever reducer

Dextromethorphan HBr 10 mg....Cough suppressant

Section 60561-8

Other information

■ each 10 mL contains: sodium 6 mg

■ store at 20-25°C (68-77°F)

■ do not refrigerate

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

Active Ingredients / Purpose

Acetaminophen 325 mg..Pain reliever/fever reducer

Dextromethorphan HBr 10 mg....Cough suppressant


Structured Label Content

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 and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

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

Section 50569-3 (50569-3)

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.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

NDC 72854-064

Children's

Mucinex®

Honey

Flavor Liquid

4 FL OZ

(118 mL)

Section 53413-1 (53413-1)

Questions? 1-866-682-4639

Section 55105-1 (55105-1)

Acetaminophen 325 mg..Pain reliever/fever reducer

Dextromethorphan HBr 10 mg....Cough suppressant

Section 60561-8 (60561-8)

Other information

■ each 10 mL contains: sodium 6 mg

■ store at 20-25°C (68-77°F)

■ do not refrigerate

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

Active Ingredients / Purpose (Active ingredients / Purpose)

Acetaminophen 325 mg..Pain reliever/fever reducer

Dextromethorphan HBr 10 mg....Cough suppressant


Advanced Ingredient Data


Raw Label Data

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