Cvs 44-057

Cvs 44-057
SPL v13
SPL
SPL Set ID eaa07dd4-cb7e-45ca-abe4-7a3f7a9d928d
Route
ORAL
Published
Effective Date 2025-12-22
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 Fd&c Red No. 40 Glycerin Propylene Glycol Water Sodium Benzoate Trisodium Citrate Dihydrate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-07-31

Description

Dextromethorphan HBr 5 mg Guaifenesin 100 mg Phenylephrine HCl 2.5 mg

Purpose

Cough suppressant Expectorant Nasal decongestant


Medication Information

Purpose

Cough suppressant

Expectorant

Nasal decongestant

Description

Dextromethorphan HBr 5 mg Guaifenesin 100 mg Phenylephrine HCl 2.5 mg

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
    • stuffy nose
    • nasal congestion due to a cold
    • the intensity of coughing
    • the impulse to cough to help the child get to sleep

Directions
  • do not take more than directed

  • do not take more than 6 doses in any 24-hour period

  • mL = milliliter

  • only use the dose cup provided

  • dose as follows or as directed by a doctor
Age

Dose

 children 6 to under 12 years  10 mL every 4 hours  

 children 4 to under 6 years

 5 mL every 4 hours

 children under 4 years

 do not use



Do Not Use

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.

Other Information
  • each 5 mL contains: sodium 3 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
Inactive Ingredients

anhydrous citric acid, FD&C red #40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose, xanthan gum

Questions Or Comments?

1-800-426-9391

Principal Display Panel

♥︎CVS

NDC 69842-570-88

Children’s

DAYTIME

MULTI-SYMPTOM

COLD

DEXTROMETHORPHAN HBr

Cough suppressant

GUAIFENESIN

Expectorant

PHENYLEPHRINE HCl

Nasal decongestant

Oral Solution

Compare to Mucinex® Children's

Multi-Symptom Cold active ingredients*

Relieves:

• Chest congestion

• Stuffy nose

• Cough

Breaks Up Mucus

No added alcohol

Free of aspirin

& ibuprofen

For Ages 4

to 11 Years

Berry Flavor

Dosage cup included

Actual Bottle Size on Side Panel

6.8 FL OZ (201 mL)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by

RB Health (US) LLC, owner of the registered trademark

Mucinex® Children’s Multi-Symptom Cold.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2025 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

100% money back

guaranteed.

CVS.com/returnpolicy

50844 ORG082405788

CVS 44-057
When Using This Product

do not exceed recommended dosage.

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 persists more than 7 days, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredients (in Each 5 Ml)

Dextromethorphan HBr 5 mg

Guaifenesin 100 mg

Phenylephrine HCl 2.5 mg

Ask A Doctor Before Use If the Child Has
  • diabetes
  • heart disease
  • thyroid disease
  • high blood pressure

  • persistent or chronic cough such as occurs with asthma
  • cough that occurs with too much phlegm (mucus)


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
    • stuffy nose
    • nasal congestion due to a cold
    • the intensity of coughing
    • the impulse to cough to help the child get to sleep

Purpose

Cough suppressant

Expectorant

Nasal decongestant

Directions
  • do not take more than directed

  • do not take more than 6 doses in any 24-hour period

  • mL = milliliter

  • only use the dose cup provided

  • dose as follows or as directed by a doctor
Age

Dose

 children 6 to under 12 years  10 mL every 4 hours  

 children 4 to under 6 years

 5 mL every 4 hours

 children under 4 years

 do not use



Do Not Use (Do not use)

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.

Other Information (Other information)
  • each 5 mL contains: sodium 3 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, FD&C red #40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel (Principal display panel)

♥︎CVS

NDC 69842-570-88

Children’s

DAYTIME

MULTI-SYMPTOM

COLD

DEXTROMETHORPHAN HBr

Cough suppressant

GUAIFENESIN

Expectorant

PHENYLEPHRINE HCl

Nasal decongestant

Oral Solution

Compare to Mucinex® Children's

Multi-Symptom Cold active ingredients*

Relieves:

• Chest congestion

• Stuffy nose

• Cough

Breaks Up Mucus

No added alcohol

Free of aspirin

& ibuprofen

For Ages 4

to 11 Years

Berry Flavor

Dosage cup included

Actual Bottle Size on Side Panel

6.8 FL OZ (201 mL)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by

RB Health (US) LLC, owner of the registered trademark

Mucinex® Children’s Multi-Symptom Cold.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2025 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

100% money back

guaranteed.

CVS.com/returnpolicy

50844 ORG082405788

CVS 44-057
When Using This Product (When using this product)

do not exceed recommended dosage.

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 persists more than 7 days, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredients (in Each 5 Ml) (Active ingredients (in each 5 mL))

Dextromethorphan HBr 5 mg

Guaifenesin 100 mg

Phenylephrine HCl 2.5 mg

Ask A Doctor Before Use If the Child Has (Ask a doctor before use if the child has)
  • diabetes
  • heart disease
  • thyroid disease
  • high blood pressure

  • persistent or chronic cough such as occurs with asthma
  • cough that occurs with too much phlegm (mucus)


Advanced Ingredient Data


Raw Label Data

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