Equate Children's Multi-symptom Cold

Equate Children's Multi-symptom Cold
SPL v4
SPL
SPL Set ID d291faa9-894e-421c-8115-8a8c2a937172
Route
ORAL
Published
Effective Date 2025-12-03
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 2014-10-01

Description

Dextromethorphan HBr 5mg Guaifenesin 100 mg Phenyephrine HCl 2.5 mg

Purpose

Cough Suppressant Expectorant Phenylephrine HCl


Medication Information

Purpose

Cough Suppressant

Expectorant

Phenylephrine HCl

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 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
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
  • mL = milliliter




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






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

Inactive Ingredients

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

Principal Display Panel

NDC 49035-715-03

equateTM

Compare to Children's Mucinex® Multi-Symptom Cold active ingredients*

Children's

Multi-Symptom Cold

Dextromethorphan HBr 5 mg

Cough Suppressant

Guaifenesin 100 mg

Expectorant

Phenylephrine HCl 2.5 mg

Nasal Decongestant

Ages 4 to 12 years

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

Very Berry Flavored 

4 FL OZ (118 mL)


When Using This Product

do not use more than directed

Ask A Doctor Before Use If
  • 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)
Stop Use and Ask 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.


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 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
Purpose (PURPOSE)

Cough Suppressant

Expectorant

Phenylephrine HCl

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
  • mL = milliliter




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






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

Inactive Ingredients (INACTIVE INGREDIENTS)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 49035-715-03

equateTM

Compare to Children's Mucinex® Multi-Symptom Cold active ingredients*

Children's

Multi-Symptom Cold

Dextromethorphan HBr 5 mg

Cough Suppressant

Guaifenesin 100 mg

Expectorant

Phenylephrine HCl 2.5 mg

Nasal Decongestant

Ages 4 to 12 years

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

Very Berry Flavored 

4 FL OZ (118 mL)


When Using This Product (WHEN USING THIS PRODUCT)

do not use more than directed

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


Advanced Ingredient Data


Raw Label Data

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