Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID da4c36f5-ec79-4489-bb18-8ddab79c34bd
Route
ORAL
Published
Effective Date 2024-06-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (5 mg) Phenylephrine (2.5 mg) Guaifenesin (100 mg) Acetaminophen (325 mg) Diphenhydramine (12.5 mg)
Inactive Ingredients
Anhydrous Citric Acid Edetate Disodium Fd&c Red No. 40 Glycerin Propylene Glycol Propyl Gallate Water Sodium Benzoate Sorbitol Sucralose Trisodium Citrate Dihydrate Xanthan Gum Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-12-31
Description

Dextromethorphan HBr 5 mg Guaifenesin 100 mg Phenylephrine HCl 2.5 mg

Purpose

Pain reliever/fever reducer  Antihistamine/Cough suppressant Nasal decongestant

Medication Information

Purpose

Pain reliever/fever reducer  Antihistamine/Cough suppressant Nasal decongestant

Description

Dextromethorphan HBr 5 mg Guaifenesin 100 mg Phenylephrine HCl 2.5 mg

Uses

Daytime

  • 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

Nighttime

  • temporarily relieves these common cold and flu symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • sneezing
    • runny nose
    • nasal congestion
    • cough
  • controls cough to help your child get to sleep
  • temporarily reduces fever 
Warnings

Nighttime only

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.

Directions

Daytime

  • do not take more than 6 doses in any 24-hour period
  • use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • keep dosing cup with product
  • dose as follows or as directed by a doctor
  • mL= milliliter
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



Nighttime

  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed (see overdose warning)
  • do not give more than 5 doses in any 24-hour period
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give more than 5 days unless directed by a doctor
  • measure only with dosing cup provided. Do not use any other dosing device
  • mL = milliliter
  • dose as follows or as directed by a doctor
  • children 6 to under 12 years of age: 10 mL every 4 hours
  • children under 6 years of age: do not use
Do Not Use

DAYTIME

  • in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certan 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 childs prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

NIGHTTIME

  • with 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.
  • with any other drug containing diphenhydramine even one used on the skin
  • if your child is allergic to acetaminophen or any of the inactive ingredients in thia product
  • to make a child sleepy
Product Label
WALGREENS Multi-Symptom Children's Cold
Other Information

Daytime

  • each 5 mL contains: sodium 5 mg
  • store between 20-25ºC (68º-77ºF). Do not refrigerate.

Nighttime

  • each 10 mL contains: sodium 6 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.



Inactive Ingredients

Inactive ingredients for Day Time 

anhydrous citric acid, EDTA disodium, FD&C red #40, flavor, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum

Inactive ingredients for Night Time 

anhydrous citric acid, EDTA disdoium, FD&C blue #1, FD&C red #40, flavor, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum

Purposes for Day Time

Cough suppressant

Expectorant

Nasal decongestant

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredients in Children's Mucinex DayTime Multi-Symptom Cold & Night Time Multi-Symptom Cold††

Children's

MULTI-SYMPTOM COLD

DEXTROMETHORPAN HBr 5 mg / COUGH SUPPRESSANT

GUAIFENESIN 100 mg / EXPECTORANT

PHENYLEPHRINE HCI 2.5 mg / NASAL DECONGESTANT

DAYTIME

ALCOHOL FREE

  • Relief from chest congestion, cough & stuffy nose
  • Breaks up mucus

AGES 4 - 11 YEARS

Berry flavor

FL OZ (mL)

children's

MULTI-SYMPTOM

ACETAMINOPHEN 325 mg / PAIN RELIEVER / FEVER REDUCER

DIPHENHYDRAMINE HCI 12.5 mg / ANTIHISTAMINE / COUGH SUPPRESSANT

PHENYLEPHRINE HCI 5 mg / NASAL DECONGESTANT

NIGHTTIME

ALCOHOL FREE

  • Relief from stuffy nose, cough, fever, sore throat, runny nose & sneezing

AGES 6 - 11 YEARS

Berry flavor

FL OZ (mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

††This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children's Mucinex® Night Time Multi-Symptom Cold and Children's Mucinex® Multi-Symptom Cold

DISTRIBUTED BY; WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

Purposes for Night Time

Pain reliever/fever reducer 

Antihistamine/Cough suppressant

Nasal decongestant

When Using This Product

Daytime

do not use more than directed.

Nighttime

  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may ocur
  • sedatives and tranquilizers may increase drowsiness
Stop Use and Ask A Doctor If

DAYTIME

  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not get better with 7 days or occur with fever
  • cough lasts more than 7 days, comes back, or occurs with a fever, rash, or headache that lasts.These could be signs of a serious condition.

These could be signs of a serious condition.

NIGHTTIME

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse or lasts more than 5 days
  • redness or swelling is present
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • 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.

Daytime

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 

Nighttime

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 (1-800-222-1222). Quick medical attention is critical even if you not notice any signs or symptoms.

Ask A Doctor Before Use your Child Has

DAYTIME

  • heart disease
  • high blood pressure
  • diabetes
  • thyroid disease
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such occurs with asthma

NIGHTTIME

  • liver disease
  • heart disease
  • high blood disease
  • diabetes
  • thyroid disease
  • glaucoma
  • a breathing problem such as chronic bronchitis
  • persistent or chronic cough such as occurs with asthma
  • cough that occurs with too much phlegm (mucus)
Active Ingredients for Day Time (in Each 5 Ml)

Dextromethorphan HBr 5 mg

Guaifenesin 100 mg

Phenylephrine HCl 2.5 mg

Active Ingredients for Night Time (in Each 10 Ml)

Acetaminophen 325 mg

Diphenhydramine HCL12.5 mg

Phenylephrine HCL5 mg

Ask A Doctor Or Pharmacist Before Use If the Child Is

NIGHTTIME

  • taking sedatives or tranquilizers.
  • taking the blood thinning drug warfarin

Structured Label Content

Uses

Daytime

  • 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

Nighttime

  • temporarily relieves these common cold and flu symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • sneezing
    • runny nose
    • nasal congestion
    • cough
  • controls cough to help your child get to sleep
  • temporarily reduces fever 
Warnings

Nighttime only

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.

Directions

Daytime

  • do not take more than 6 doses in any 24-hour period
  • use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • keep dosing cup with product
  • dose as follows or as directed by a doctor
  • mL= milliliter
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



Nighttime

  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed (see overdose warning)
  • do not give more than 5 doses in any 24-hour period
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give more than 5 days unless directed by a doctor
  • measure only with dosing cup provided. Do not use any other dosing device
  • mL = milliliter
  • dose as follows or as directed by a doctor
  • children 6 to under 12 years of age: 10 mL every 4 hours
  • children under 6 years of age: do not use
Do Not Use (Do not use)

DAYTIME

  • in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certan 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 childs prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

NIGHTTIME

  • with 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.
  • with any other drug containing diphenhydramine even one used on the skin
  • if your child is allergic to acetaminophen or any of the inactive ingredients in thia product
  • to make a child sleepy
Product Label
WALGREENS Multi-Symptom Children's Cold
Other Information (Other information)

Daytime

  • each 5 mL contains: sodium 5 mg
  • store between 20-25ºC (68º-77ºF). Do not refrigerate.

Nighttime

  • each 10 mL contains: sodium 6 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.



Inactive Ingredients (Inactive ingredients)

Inactive ingredients for Day Time 

anhydrous citric acid, EDTA disodium, FD&C red #40, flavor, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum

Inactive ingredients for Night Time 

anhydrous citric acid, EDTA disdoium, FD&C blue #1, FD&C red #40, flavor, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum

Purposes for Day Time

Cough suppressant

Expectorant

Nasal decongestant

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredients in Children's Mucinex DayTime Multi-Symptom Cold & Night Time Multi-Symptom Cold††

Children's

MULTI-SYMPTOM COLD

DEXTROMETHORPAN HBr 5 mg / COUGH SUPPRESSANT

GUAIFENESIN 100 mg / EXPECTORANT

PHENYLEPHRINE HCI 2.5 mg / NASAL DECONGESTANT

DAYTIME

ALCOHOL FREE

  • Relief from chest congestion, cough & stuffy nose
  • Breaks up mucus

AGES 4 - 11 YEARS

Berry flavor

FL OZ (mL)

children's

MULTI-SYMPTOM

ACETAMINOPHEN 325 mg / PAIN RELIEVER / FEVER REDUCER

DIPHENHYDRAMINE HCI 12.5 mg / ANTIHISTAMINE / COUGH SUPPRESSANT

PHENYLEPHRINE HCI 5 mg / NASAL DECONGESTANT

NIGHTTIME

ALCOHOL FREE

  • Relief from stuffy nose, cough, fever, sore throat, runny nose & sneezing

AGES 6 - 11 YEARS

Berry flavor

FL OZ (mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

††This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children's Mucinex® Night Time Multi-Symptom Cold and Children's Mucinex® Multi-Symptom Cold

DISTRIBUTED BY; WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

Purposes for Night Time

Pain reliever/fever reducer 

Antihistamine/Cough suppressant

Nasal decongestant

When Using This Product (When using this product)

Daytime

do not use more than directed.

Nighttime

  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may ocur
  • sedatives and tranquilizers may increase drowsiness
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

DAYTIME

  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not get better with 7 days or occur with fever
  • cough lasts more than 7 days, comes back, or occurs with a fever, rash, or headache that lasts.These could be signs of a serious condition.

These could be signs of a serious condition.

NIGHTTIME

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse or lasts more than 5 days
  • redness or swelling is present
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • 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.)

Daytime

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 

Nighttime

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 (1-800-222-1222). Quick medical attention is critical even if you not notice any signs or symptoms.

Ask A Doctor Before Use your Child Has (Ask a doctor before use your child has)

DAYTIME

  • heart disease
  • high blood pressure
  • diabetes
  • thyroid disease
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such occurs with asthma

NIGHTTIME

  • liver disease
  • heart disease
  • high blood disease
  • diabetes
  • thyroid disease
  • glaucoma
  • a breathing problem such as chronic bronchitis
  • persistent or chronic cough such as occurs with asthma
  • cough that occurs with too much phlegm (mucus)
Active Ingredients for Day Time (in Each 5 Ml) (Active ingredients for Day Time (in each 5 mL))

Dextromethorphan HBr 5 mg

Guaifenesin 100 mg

Phenylephrine HCl 2.5 mg

Active Ingredients for Night Time (in Each 10 Ml) (Active ingredients for Night Time (in each 10 mL))

Acetaminophen 325 mg

Diphenhydramine HCL12.5 mg

Phenylephrine HCL5 mg

Ask A Doctor Or Pharmacist Before Use If the Child Is (Ask a doctor or pharmacist before use if the child is)

NIGHTTIME

  • taking sedatives or tranquilizers.
  • taking the blood thinning drug warfarin

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Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:11.099017 · Updated: 2026-03-14T23:03:07.791514