Children's Multi-symptom Cold Daytime

Children's Multi-symptom Cold Daytime
SPL v3
SPL
SPL Set ID 1768677d-96ec-f9f7-e063-6394a90a4ef4
Route
ORAL
Published
Effective Date 2025-11-21
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 D&c Red No. 33 Dextrose 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

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-14

Description

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

Use(s)
  • 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
Warnings

.

Directions
  • 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






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

Dextromethorphan HBr 5mg

Guaifenesin 100 mg

Phenyephrine HCl 2.5 mg

Questions Or Comments?

Call 1-888-287-1915

Principal Display Panel

NDC79903-270-03

equateTM

 

Daytime

Ages 4-12 years

Children's 

 Multi-Symptom Cold

 

Dextromethorphan HBr 5 mg -

Cough Suppressant

Guaifenesin 100 mg - Expectorant

Phenylephrine HCl 2.5 mg - 

Nasal Decongestant



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

Dosage Cup IncludedAlcohol FreeVery Berry Flavored 

4 FL OZ (118 mL)

 



 

When Using This Product
  • do not use more than directed
Inactive Ingredient Section

 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, propyl paraben, purified water, saccharin sodium, sodium hydroxide, sorbitol solution, sucralose, xanthan gum.

Stop Use and Ask A Doctor If
  • 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.

Keep Out of Reach of Children.

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

Ask A Doctor Before Use If the Child Has
  • 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)

Structured Label Content

Use(s) (USE(S))
  • 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
Purpose (PURPOSE)

Cough suppressant

Expectorant

Nasal decongestant

Warnings (WARNINGS)

.

Directions (DIRECTIONS)
  • 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






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: potassium 5 mg, sodium 5 mg
  • store between 15-30°C (59-86°F)
  • do not refrigerate
  • dosing cup provided
Active Ingredient(s) (ACTIVE INGREDIENT(S))

Dextromethorphan HBr 5mg

Guaifenesin 100 mg

Phenyephrine HCl 2.5 mg

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Call 1-888-287-1915

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC79903-270-03

equateTM

 

Daytime

Ages 4-12 years

Children's 

 Multi-Symptom Cold

 

Dextromethorphan HBr 5 mg -

Cough Suppressant

Guaifenesin 100 mg - Expectorant

Phenylephrine HCl 2.5 mg - 

Nasal Decongestant



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

Dosage Cup IncludedAlcohol FreeVery Berry Flavored 

4 FL OZ (118 mL)

 



 

When Using This Product (WHEN USING THIS PRODUCT)
  • do not use more than directed
Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

 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, propyl paraben, purified water, saccharin sodium, sodium hydroxide, sorbitol solution, sucralose, xanthan gum.

Stop Use and Ask A Doctor If (STOP USE AND ASK A DOCTOR IF)
  • 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.

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.

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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)