Family Wellness Children's Mucus Relif 552

Family Wellness Children's Mucus Relif 552
SPL v1
SPL
SPL Set ID 07ad76cc-2a6c-4a88-a5e9-5e8f6d1319e3
Route
ORAL
Published
Effective Date 2024-04-17
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 2024-04-17

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.



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, D&C red #33, dextrose, 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

FAMILY Wellness TM

COMPARE TO THE ACTIVE INGREDIENTS IN CHILDREN'S MUCINEX COUGH*



children's 

MUCUS RELIEF

AGES 4-12 YEARS



COUGH SUPPRESSANT & EXPECTORANT

 

Dextromethorphan HBr 5mg

Guaifenesin 100 mg



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


     CHERRY FLAVORED LIQUID

     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.



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, D&C red #33, dextrose, 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)

FAMILY Wellness TM

COMPARE TO THE ACTIVE INGREDIENTS IN CHILDREN'S MUCINEX COUGH*



children's 

MUCUS RELIEF

AGES 4-12 YEARS



COUGH SUPPRESSANT & EXPECTORANT

 

Dextromethorphan HBr 5mg

Guaifenesin 100 mg



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


     CHERRY FLAVORED LIQUID

     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)