Daytime Nighttime Children's Multi-symptom Cold 

Daytime Nighttime Children's Multi-symptom Cold 
SPL v2
SPL
SPL Set ID 177e3247-402d-98e4-e063-6294a90ae068
Route
ORAL
Published
Effective Date 2024-12-02
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (5 mg) Guaifenesin (100 mg) Phenylephrine (2.5 mg) Acetaminophen (325 mg) Diphenhydramine (12.5 mg)
Inactive Ingredients
Anhydrous Citric Acid D&c Red No. 33 Dextrose, Unspecified Form Edetate Disodium Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Methylparaben Potassium Sorbate Propyl Gallate Propylene Glycol Propylparaben Water Saccharin Sodium Sodium Hydroxide Sorbitol Sucralose Xanthan Gum Sodium Benzoate Sodium Citrate

Identifiers & Packaging

Pill Appearance
Color: red Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-26
Description

Dextromethorphan HBr 5mg 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 5mg Guaifenesin 100 mg Phenylephrine HCl 2.5 mg

Use(s)


DAYTIME

  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • temporarily relieves:
  • cough due to minor throat and bronchial irritation as may occur with a 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:
  • cough
  • sore throat
  • nasal congestion
  • runny nose
  • minor aches and pains
  • headache
  • sinus congestion and pressure
  • sneezing
  • temporarily reduces fever
  • controls cough to help your child get to sleep
Warnings

NIGHTTIME



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
  • 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   10 mL every 4 hours
children 4 years to under 6 years  5 mL every 4 hours
children under 4 years  do not use
  • mL = milliliter


NIGHTTIME



  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed (see Overdose warning)
  • shake well before use
  • 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 dosing cup with other products
  • dose as follows or as directed by a doctor
  • mL = milliliter
  • children 6 to under 12 years of age: 10 mL in dosing cup provided.
  • 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) (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.



NIGHTTIME



  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on the skin
  • 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 MAOI drug. If you do not know if your child prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Other Information


DAYTIME

  • each 5 mL contains: potassium 5 mg, sodium 5 mg
  • store between 15-30°C (59-86°F)
  • do not refrigerate
  • dosing cup provided




NIGHTTIME



  • each 10 mL contains: sodium 10 mg
  • store between 15-30°C (59-86°F)
  • do not refrigerate
  • dosing cup provided
Purpose for Daytime

Cough Suppressant

Expectorant

Nasal decongestant

Inactive Ingredients

DAYTIME

citric acid anhydrous, D&C red # 33, dextrose, edetate disodium, FD&C blue # 1, FD&C Red #40, flavor, glycerin, methylparaben, potassium sorbate, propyl gallate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sorbitol solution, sucralose, xanthan gum.



NIGHTTIME

citric acid anhydrous, edetate disodium, FD&C blue # 1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum.

Purpose for Nighttime

Pain reliever/fever reducer

Antihistamine/Cough Suppressant

Nasal decongestant

Questions Or Comments?

call 1-888-287-1915

Principal Display Panel

DAY & NIGHT VALUE PACK

NDC 49035-938-04

equateTM

Compare to Children's Mucinex®Multi-Symptom Cold Active Ingredients*

Daytime

Ages 4-12 years

Children's Multi-Symptom Cold

Dextromethorphan HBr 5mg   - Cough Suppressant 

Guaifenesin 100mg - Expectorant

Phenylephrine HCl 2.5 mg - Nasal Decongestant

  •  Relieves Stuffy Nose
  • Soothes Cough
  • Relieves Chest Congestion
  • Thins & loosens Mucus

Very Berry Flavored 

Dosage cup included

NIGHTTIME

Ages 6-12 years Children's Multi-Symptom Cold Acetaminophen 325mg - Pain reliever/fever reducer Diphenhydramine HCl 12.5mg - Antihistamine/cough suppressant

Phenylephrine HCl 5 mg - Nasal Decongestant

  • Temporarily reduces fever
  • Soothes cough & sore throat
  • Relieves nasal congestion & sneezing

Mixed berry flavored  Dosage Cup Included

TWO 4 FL OZ (118 mL) BOTTLES / 8 FL OZ (236 mL) TOTAL

When Using This Product

DAYTIME 

do not use more than directed

NIGHTTIME

  • do not use more than directed (see Overdose warning)
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
Stop Use and Ask Doctor If


DAYTIME

  • your child gets nervous, dizzy or sleepless
  • 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 illness.



NIGHTTIME



  • nervousness, dizziness or sleeplessness occur
  • pain, nasal congestion 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 fever, 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 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. Quick medical attention is critical even if you do not notice any signs or symptoms.

Ask A Doctor Before Use If Child Has


DAYTIME

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


NIGHTTIME



  • liver disease
  • thyroid disease
  • diabetes
  • heart disease
  • high blood pressure
  • 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 Ingredient(s) for Daytime (in Each 5 Ml)

Dextromethorphan HBr 5mg

Guaifenesin 100 mg

Phenylephrine HCl 2.5 mg

Active Ingredient(s) for Nighttime (in Each 10 Ml)

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

Phenylephrine HCl 5 mg

Ask A Doctor Or Pharmacist Before Use If Your Child

NIGHTTIME



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

Structured Label Content

Use(s) (USE(S))


DAYTIME

  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • temporarily relieves:
  • cough due to minor throat and bronchial irritation as may occur with a 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:
  • cough
  • sore throat
  • nasal congestion
  • runny nose
  • minor aches and pains
  • headache
  • sinus congestion and pressure
  • sneezing
  • temporarily reduces fever
  • controls cough to help your child get to sleep
Warnings (WARNINGS)

NIGHTTIME



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 (DIRECTIONS)


DAYTIME

  • do not take 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   10 mL every 4 hours
children 4 years to under 6 years  5 mL every 4 hours
children under 4 years  do not use
  • mL = milliliter


NIGHTTIME



  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed (see Overdose warning)
  • shake well before use
  • 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 dosing cup with other products
  • dose as follows or as directed by a doctor
  • mL = milliliter
  • children 6 to under 12 years of age: 10 mL in dosing cup provided.
  • 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) (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.



NIGHTTIME



  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on the skin
  • 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 MAOI drug. If you do not know if your child prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Other Information (OTHER INFORMATION)


DAYTIME

  • each 5 mL contains: potassium 5 mg, sodium 5 mg
  • store between 15-30°C (59-86°F)
  • do not refrigerate
  • dosing cup provided




NIGHTTIME



  • each 10 mL contains: sodium 10 mg
  • store between 15-30°C (59-86°F)
  • do not refrigerate
  • dosing cup provided
Purpose for Daytime (PURPOSE FOR DAYTIME)

Cough Suppressant

Expectorant

Nasal decongestant

Inactive Ingredients (INACTIVE INGREDIENTS)

DAYTIME

citric acid anhydrous, D&C red # 33, dextrose, edetate disodium, FD&C blue # 1, FD&C Red #40, flavor, glycerin, methylparaben, potassium sorbate, propyl gallate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sorbitol solution, sucralose, xanthan gum.



NIGHTTIME

citric acid anhydrous, edetate disodium, FD&C blue # 1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum.

Purpose for Nighttime (PURPOSE FOR NIGHTTIME)

Pain reliever/fever reducer

Antihistamine/Cough Suppressant

Nasal decongestant

Questions Or Comments? (QUESTIONS OR COMMENTS?)

call 1-888-287-1915

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

DAY & NIGHT VALUE PACK

NDC 49035-938-04

equateTM

Compare to Children's Mucinex®Multi-Symptom Cold Active Ingredients*

Daytime

Ages 4-12 years

Children's Multi-Symptom Cold

Dextromethorphan HBr 5mg   - Cough Suppressant 

Guaifenesin 100mg - Expectorant

Phenylephrine HCl 2.5 mg - Nasal Decongestant

  •  Relieves Stuffy Nose
  • Soothes Cough
  • Relieves Chest Congestion
  • Thins & loosens Mucus

Very Berry Flavored 

Dosage cup included

NIGHTTIME

Ages 6-12 years Children's Multi-Symptom Cold Acetaminophen 325mg - Pain reliever/fever reducer Diphenhydramine HCl 12.5mg - Antihistamine/cough suppressant

Phenylephrine HCl 5 mg - Nasal Decongestant

  • Temporarily reduces fever
  • Soothes cough & sore throat
  • Relieves nasal congestion & sneezing

Mixed berry flavored  Dosage Cup Included

TWO 4 FL OZ (118 mL) BOTTLES / 8 FL OZ (236 mL) TOTAL

When Using This Product (WHEN USING THIS PRODUCT)

DAYTIME 

do not use more than directed

NIGHTTIME

  • do not use more than directed (see Overdose warning)
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
Stop Use and Ask Doctor If (STOP USE AND ASK DOCTOR IF)


DAYTIME

  • your child gets nervous, dizzy or sleepless
  • 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 illness.



NIGHTTIME



  • nervousness, dizziness or sleeplessness occur
  • pain, nasal congestion 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 fever, 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 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. Quick medical attention is critical even if you do not notice any signs or symptoms.

Ask A Doctor Before Use If Child Has (ASK A DOCTOR BEFORE USE IF CHILD HAS)


DAYTIME

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


NIGHTTIME



  • liver disease
  • thyroid disease
  • diabetes
  • heart disease
  • high blood pressure
  • 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 Ingredient(s) for Daytime (in Each 5 Ml) (ACTIVE INGREDIENT(S) FOR DAYTIME (in each 5 mL))

Dextromethorphan HBr 5mg

Guaifenesin 100 mg

Phenylephrine HCl 2.5 mg

Active Ingredient(s) for Nighttime (in Each 10 Ml) (ACTIVE INGREDIENT(S) FOR NIGHTTIME (in each 10 mL))

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

Phenylephrine HCl 5 mg

Ask A Doctor Or Pharmacist Before Use If Your Child (ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOUR CHILD)

NIGHTTIME



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

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Raw Label Data

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Source: dailymed · Ingested: 2026-02-15T12:04:34.969698 · Updated: 2026-03-14T23:05:26.862879