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

Purpose

Cough suppressant Expectorant Nasal decongestant

Description

Dextromethorphan HBr 5mg Guaifenesin 100 mg Phenyephrine HCl 2.5 mg


Medication Information

Warnings

.

Purpose

Cough suppressant

Expectorant

Nasal decongestant

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






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
Description

Dextromethorphan HBr 5mg Guaifenesin 100 mg Phenyephrine HCl 2.5 mg

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)

 



 

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
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.

Active Ingredient(s)

Dextromethorphan HBr 5mg

Guaifenesin 100 mg

Phenyephrine HCl 2.5 mg

Questions Or Comments?

Call 1-888-287-1915

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

Warnings (WARNINGS)

.

Purpose (PURPOSE)

Cough suppressant

Expectorant

Nasal decongestant

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






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
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)

 



 

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
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.

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

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)