Equate Children's Cough Liquid

Equate Children's Cough Liquid
SPL v4
SPL
SPL Set ID 50a0eaa5-fa73-4d84-86fc-3546c85cf353
Route
ORAL
Published
Effective Date 2024-12-20
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (5 mg) Guaifenesin (100 mg)
Inactive Ingredients
Anhydrous Citric Acid Dextrose, Unspecified Form D&c Red No. 33 Fd&c Red No. 40 Glycerin Methylparaben Potassium Sorbate Propylene Glycol Propylparaben Water Saccharin Sodium Sorbitol Sodium Hydroxide Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-08-01

Description

Dextromethorphan HBr 5 mg Guaifenesin 100 mg

Purpose

Cough suppressant Expectorant


Medication Information

Purpose

Cough suppressant

Expectorant

Description

Dextromethorphan HBr 5 mg Guaifenesin 100 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 impulse to cough to help your child get to sleep 
  • the intensity of coughing
Warning

.

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
  • mL=milliliter




Age   Dose
 children 6 years to under 12 years  5 mL-10 mL

every 4 hours
 children 4 years to under 6 years  2.5 mL - 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.



Questions?

1-888-287-1915

Other Information
  • each 5 mL contains: potassium 5 mg, sodium 5 mg
  • store between 20 to 25°C (68 to 77°F)
  • do not refrigerate
  • dosing cup provided
Inactive Ingredients

citric acid anhydrous, dextrose, D&C red#33, FD&C red#40, flavor, glycerin, methylparaben, potassium sorbate, propylene glycol, propyl paraben, purified water, saccharin sodium, sodium hydroxide, sorbitol, sucralose, xanthan gum

Principal Display Panel

NDC 49035-773-03

equate

Compare to Children's Mucinex® Cough active ingredients*

children's 

COUGH LIQUID

Dextromethorphan HBr 5mg

Cough Suppressant

Guaifenesin 100 mg

Expectorant

AGES 4 TO 12 YEARS



  • Controls cough
  • Thins and Loosens Mucus
  • Relieves chest congestion
  • Non-Drowsy
  • Alcohol Free

Cherry Flavored

4 FL OZ (118 mL)









Stop Use and A Ask Doctor If
  •  cough lasts more than 7 days, comes back, or is accompanied by 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

Active Ingredients (in Each 5 Ml)

Dextromethorphan HBr 5 mg

Guaifenesin 100 mg

Ask A Doctor Before Use If You Have
  • 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 impulse to cough to help your child get to sleep 
  • the intensity of coughing
Purpose (PURPOSE)

Cough suppressant

Expectorant

Warning (WARNING)

.

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
  • mL=milliliter




Age   Dose
 children 6 years to under 12 years  5 mL-10 mL

every 4 hours
 children 4 years to under 6 years  2.5 mL - 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.



Questions? (QUESTIONS?)

1-888-287-1915

Other Information (OTHER INFORMATION)
  • each 5 mL contains: potassium 5 mg, sodium 5 mg
  • store between 20 to 25°C (68 to 77°F)
  • do not refrigerate
  • dosing cup provided
Inactive Ingredients (INACTIVE INGREDIENTS)

citric acid anhydrous, dextrose, D&C red#33, FD&C red#40, flavor, glycerin, methylparaben, potassium sorbate, propylene glycol, propyl paraben, purified water, saccharin sodium, sodium hydroxide, sorbitol, sucralose, xanthan gum

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 49035-773-03

equate

Compare to Children's Mucinex® Cough active ingredients*

children's 

COUGH LIQUID

Dextromethorphan HBr 5mg

Cough Suppressant

Guaifenesin 100 mg

Expectorant

AGES 4 TO 12 YEARS



  • Controls cough
  • Thins and Loosens Mucus
  • Relieves chest congestion
  • Non-Drowsy
  • Alcohol Free

Cherry Flavored

4 FL OZ (118 mL)









Stop Use and A Ask Doctor If (STOP USE AND A ASK DOCTOR IF)
  •  cough lasts more than 7 days, comes back, or is accompanied by 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

Active Ingredients (in Each 5 Ml) (ACTIVE INGREDIENTS (in each 5 mL))

Dextromethorphan HBr 5 mg

Guaifenesin 100 mg

Ask A Doctor Before Use If You Have (ASK A DOCTOR BEFORE USE IF YOU HAVE)
  • 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)