Winco Mucinex® Children's Multi-symptom Cold

Winco Mucinex® Children's Multi-symptom Cold
SPL v6
SPL
SPL Set ID 1d02b32a-e88d-4c70-b66d-7bdc22c25a43
Route
ORAL
Published
Effective Date 2025-12-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (5 mg) Guaifenesin (100 mg) Phenylephrine (2.5 mg)
Inactive Ingredients
Anhydrous Citric Acid Edetate Disodium Fd&c Red No. 40 Potassium Citrate Propyl Gallate Propylene Glycol Water Sodium Benzoate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-03-30

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • 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
    • nasal congestion due to a cold
    • stuffy nose
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Section 50567-7

When using this product do not use more than directed

Section 50570-1

Do not usein 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 55105-1
Active ingredients

(in each 5 mL)
Purposes

Dextromethorphan HBr 5 mg

Cough suppressant

Guaifenesin 100 mg

Expectorant

Phenylephrine HCl 2.5 mg

Nasal decongestant

Directions
  • do not give more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
Age Dose

children 6 years to under 12 years of age

10 mL every 4 hours

children 4 to under 6 years of age

5 mL every 4 hours

children under 4 years of age

do not use

Other Information
  • each 5 mL contains:sodium 2 mg
  • store at room temperature
  • do not refrigerate
  • use dosing cup provided
Inactive Ingredients

anhydrous citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavors, potassium citrate, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions Or Comments?

1-866-467-2748

Stop Use and Ask A Doctor If
  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not get better within 7 days or occur with fever
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.
Ask A Doctor Before Use If the Child Has
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with asthma
Principal Display Panel 118 Ml Bottle Carton

NDC 67091-355-18

Children's

Multi-Symptom

Cold

Dextromethorphan HBr-Cough Suppressant

Guaifenesin- Expectorant

Phenylephrine HCl - Nasal Decongestant

  • Relieves Stuffy Nose
  • Controls Cough
  • Relieves Chest Congestion
  • Breaks up Mucus

Dosing Cup Included

For Ages 4 & Over

Berry Flavor

Naturally and Artificially Flavored

4 FL OZ (118 mL)

IMPORTANT:Keep this carton for future reference on full labeling.

TAMPER-EVEDENT:DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING.

Distributed by:

*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children’s Mucinex® Multi-Symptom Cold.


Structured Label Content

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • 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
    • nasal congestion due to a cold
    • stuffy nose
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Section 50567-7 (50567-7)

When using this product do not use more than directed

Section 50570-1 (50570-1)

Do not usein 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 55105-1 (55105-1)
Active ingredients

(in each 5 mL)
Purposes

Dextromethorphan HBr 5 mg

Cough suppressant

Guaifenesin 100 mg

Expectorant

Phenylephrine HCl 2.5 mg

Nasal decongestant

Directions
  • do not give more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
Age Dose

children 6 years to under 12 years of age

10 mL every 4 hours

children 4 to under 6 years of age

5 mL every 4 hours

children under 4 years of age

do not use

Other Information (Other information)
  • each 5 mL contains:sodium 2 mg
  • store at room temperature
  • do not refrigerate
  • use dosing cup provided
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavors, potassium citrate, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

1-866-467-2748

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not get better within 7 days or occur with fever
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.
Ask A Doctor Before Use If the Child Has (Ask a doctor before use if the child has)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with asthma
Principal Display Panel 118 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton)

NDC 67091-355-18

Children's

Multi-Symptom

Cold

Dextromethorphan HBr-Cough Suppressant

Guaifenesin- Expectorant

Phenylephrine HCl - Nasal Decongestant

  • Relieves Stuffy Nose
  • Controls Cough
  • Relieves Chest Congestion
  • Breaks up Mucus

Dosing Cup Included

For Ages 4 & Over

Berry Flavor

Naturally and Artificially Flavored

4 FL OZ (118 mL)

IMPORTANT:Keep this carton for future reference on full labeling.

TAMPER-EVEDENT:DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING.

Distributed by:

*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children’s Mucinex® Multi-Symptom Cold.


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